- feeds
- popular
- recent
- reader
- about
- story
- technologies
- what is rss
- connect
- dmca
- contact
- Feed Preview CAP TODAY
NxTag respiratory panel v2 gets FDA clearance
May 17, 2024—Diasorin received FDA 510(k) clearance for its NxTag Respiratory Pathogen Panel v2. The post NxTag respiratory panel v2 gets FDA clearance first appeared on CAP TODAY .
BD Onclarity HPV assay approved for self-collected samples
May 16, 2024—BD announced FDA approval of the BD Onclarity HPV assay for the use of self-collected vaginal specimens for HPV testing when cervical specimens cannot otherwise be obtained. The ...
Roche gets approval for HPV self-collection solution
May 15, 2024—The FDA has approved Roche’s HPV self-collection solution for use with the company’s Cobas HPV test. The post Roche gets approval for HPV self-collection solution first appe...
PixCell adds distribution partners in the U.S.
May 2024—PixCell Medical announced a strategic distribution partnership with Medline, Henry Schein, and Thermo Fisher Scientific to increase accessibility to its flagship product, the HemoScree...
FDA clears Pathfast POC hs-cTnI test
May 2024—Polymedco announced FDA 510(k) clearance of the Pathfast hs-cTnI-II, a high-sensitivity cardiac troponin assay for the diagnosis of myocardial infarction at the point of care. The tes...
Quantimetrix Dipper POCT now with integrated barcode
May 2024—Quantimetrix announced that its Dipper POCT urinalysis dipstick control pouches now include a barcode. The integrated barcode is designed to streamline the workflow and reduce errors t...
Leica publishes guide to good histology practice
May 2024—Leica Biosystems has published “101 Steps to Better Histology—A Practical Guide to Good Histology Practice,” written by histology consultant Geoffrey Rolls. The guide provides pr...
Bio-Rad expands availability of Unity Next Peer QC
May 2024—Bio-Rad Laboratories has launched its Unity Next Peer QC data management software in Europe, the Middle East, and Africa. The software is designed to help troubleshoot quality control ...
Abbott TBI cartridge cleared for use with whole blood
May 2024—Abbott’s i-Stat TBI cartridge has received FDA clearance for use with whole blood, allowing clinicians to help assess patients with suspected concussion at the patient’s bedside. T...
FDA approves OncoReveal CDx on Illumina MiSeq Dx system
May 2024—Pillar Biosciences announced that the FDA has approved the company’s premarket approval supplement application for its OncoReveal CDx pan-cancer solid tumor in vitro diagnostic assay...
Bruker to acquire NanoString for $392.6 million
May 2025—NanoString Technologies announced that substantially all of its assets will be acquired by Bruker Corp. for approximately $392.6 million in cash consideration, plus the assumption of c...
FDA grants de novo classification for plasma cell enrichment kit
May 2024—Stemcell Technologies announced that the FDA has granted de novo classification for its immunomagnetic plasma cell enrichment kit. The EasySep Human Bone Marrow CD138 Positive Selectio...
Newcomer Supply to distribute HistoCyte cell line controls
May 2024—Newcomer Supply announced it is distributing HistoCyte Laboratories cell line controls for research use only. HistoCyte uses proprietary methods to process cell lines into tissue-like ...
FDA clears Scopio Labs digital bone marrow aspirate application
May 2024—Scopio Labs announced it has been granted de novo clearance by the FDA for its Full-Field Bone Marrow Aspirate application for use on the company’s X100 and X100HT platforms. The app...
Recordati Rare Diseases introduces educational website
May 2024—Recordati Rare Diseases has introduced its new educational website, Think iMCD, at https://thinkimcd.us . The platform is tailored for pathologists and offers comprehensive support for...
Leica gets 510(k) clearance for Aperio GT 450 DX
May 2024—Leica Biosystems announced that its flagship digital pathology slide scanner, the Aperio GT 450 DX, has received FDA 510(k) clearance. The scanner offers continuous rack loading and ca...
Bosch, Randox invest €150 million in Vivalytic platform
May 2024—Bosch and Randox Laboratories have entered into a strategic partnership in which the two companies will invest around €150 million in joint research, development, and distribution fo...
Verichem updates data reduction software
May 2024—Verichem Laboratories has upgraded its Web-based, CLIA-compliant data reduction and test reporting software. The new version allows customers to save reports on the company’s server ...
Labcorp wins bid for select assets of Invitae
May 2024—Labcorp announced it will purchase select assets of genetics company Invitae for $239 million. The company expects the transaction to generate about $275 to $300 million in annual reve...
Sysmex now selling hemostasis products under its brand
May 2024—Sysmex America announced it will sell hemostasis instruments and reagents to laboratories in the United States under the company’s mutual original equipment manufacturer agreement wi...
FDA clears QIAstat-Dx respiratory syndromic testing panel
May 13, 2024—Qiagen announced that the FDA has cleared its QIAstat-Dx Respiratory Panel Plus syndromic test for clinical use. The post FDA clears QIAstat-Dx respiratory syndromic testing pane...
FDA clears Halo AP Dx digital pathology platform
May 8, 2024—Indica Labs received FDA 510(k) clearance for its Halo AP Dx digital pathology platform for use in primary diagnosis. The post FDA clears Halo AP Dx digital pathology platform f...
Quest to acquire PathAI Diagnostics
May 1, 2024—Quest Diagnostics and PathAI announced a multifaceted collaboration designed to accelerate the adoption of digital and AI pathology innovations. The post Quest to acquire PathAI D...
Can’t find the product you need? See how custom products are born at Puritan.
It all starts with a great idea! Puritan Custom Manufacturing will work with you to create the custom swab or media product you need but you can’t find on the market. LEARN MORE . The post Ca...
Leica gets 510(k) clearance for Aperio GT 450 DX
April 29, 2024—Leica Biosystems announced that its flagship digital pathology slide scanner, the Aperio GT 450 DX, has received FDA 510(k) clearance. The post Leica gets 510(k) clearance for ...
Labcorp wins bid for select assets of Invitae
April 26, 2024—Labcorp announced it will purchase select assets of genetics company Invitae for $239 million. The post Labcorp wins bid for select assets of Invitae first appeared on CAP TOD...
FDA clears Scopio digital bone marrow aspirate application
April 25, 2024—Scopio Labs announced it has been granted de novo clearance by the FDA for its Full-Field Bone Marrow Aspirate application for use on the company’s X100 and X100HT platforms. ...
FDA approves OncoReveal CDx on Illumina MiSeq Dx system
April 23, 2024—Pillar Biosciences announced that the FDA has approved the company’s premarket approval supplement application for the OncoReveal CDx pan-cancer solid tumor in vitro diagnostic...
Leica publishes guide to good histology practice
April 22, 2024—Leica Biosystems has published "101 steps to better histology—a practical guide to good histology practice," written by histology consultant Geoffrey Rolls. The post Leica pu...
Clinical Lab 2.0 honors laboratory team excellence
Clinical Lab 2.0, a Project Santa Fe Foundation initiative, released a proclamation during Medical Laboratory Professionals Week, April 14–20, to recognize and celebrate the roles of laboratory...
Bruker to acquire NanoString Technologies for $392.6 million
April 19, 2024—NanoString Technologies announced that substantially all of its assets will be acquired by Bruker Corp. The post Bruker to acquire NanoString Technologies for $392.6 million f...
Register for our upcoming webinar
GENOMIC PROFILE AVAILABILITY IMPACT ON NSCLC PATIENT OUTCOMES IN REAL WORLD STUDY AND DAILY PRACTICE THURSDAY, JUNE 13, 2024, 1:00 PM–2:00 PM ET Webinar presenters MELINA MARMARELIS, MD, M...
Quantimetrix Dipper POCT now with integrated barcode
April 18, 2024—Quantimetrix announced that its Dipper POCT urinalysis dipstick control pouches now include a barcode. The post Quantimetrix Dipper POCT now with integrated barcode first appe...
FDA clears Diasorin Liaison Plex system
April 2024—Diasorin announced FDA 510(k) clearance for its Liaison Plex platform and Flex respiratory assay. The fully automated, sample-to-answer system uses room-temperature–stable consumab...
FDA approves test to screen for malaria in blood donors
April 2024—Roche announced FDA approval of the Cobas Malaria test, a qualitative in vitro nucleic acid screening test for the direct detection of Plasmodium RNA and DNA in whole blood samples f...
Bio-Rad gets My Green Lab certification
April 2024—Bio-Rad Laboratories announced it received My Green Lab certification for its R&D facilities in Irvine, Calif. It has been certified at My Green Lab’s highest rating, green, which ...
De novo classification granted for ADAMTS13 activity test
April 2024—Technoclone and its distributor in the United States, DiaPharma Group, announced that the FDA has granted de novo classification for the Technozym ADAMTS13 Activity ELISA. The assay ...
Bayer, Thermo Fisher to develop NGS CDx assays
April 2024—Bayer and Thermo Fisher Scientific announced that they will develop next-generation sequencing–based companion diagnostic assays to help identify patients who may benefit from Baye...
Verichem releases microprotein reference materials
April 2024—Verichem Laboratories offers a multilevel set of clinical reference materials intended for the calibration verification of clinical systems testing for total protein and albumin in u...
SpotFire R/ST panel gets 510(k) clearance, CLIA waiver
April 2024—BioMérieux has received FDA 510(k) clearance and CLIA waiver approval for the BioFire SpotFire Respiratory/Sore Throat (R/ST) panel. The multiplex PCR test is for the detection and ...
Sekisui gets EUA for Osom flu, SARS-CoV-2 test
April 2024—Sekisui Diagnostics has received emergency use authorization for its Osom Flu SARS-CoV-2 Combo test for use in professional and home testing settings. The lateral flow immunochromato...
Bio-Rad launches QC online learning center
April 2024—Bio-Rad Laboratories has launched its online Quality Controls Learning Center, a free resource designed to provide laboratories with the educational resources needed to maintain qual...
StatLab acquires Poly Scientific R&D
April 2024—StatLab Medical Products announced the acquisition of Poly Scientific R&D, a manufacturer and supplier of pathology stains, reagents, and paraffin for anatomic pathology laboratories...
FDA clears Sebia free light chain assays
April 2024—Sebia announced it has received FDA 510(k) clearance for its free light chain kappa and lambda assays, intended to aid in diagnosing and monitoring patients who have multiple myeloma...
Siemens offers anti-müllerian hormone assay
April 2024—Siemens Healthineers now offers the Anti-Müllerian Hormone assay to evaluate ovarian reserve. The assay runs on the Atellica IM analyzer and Advia Centaur immunoassay systems from s...
CAP TODAY
REGISTER FOR OUR UPCOMING WEBINAR VIRTUAL ROUNDTABLE: OPTIMIZING TESTING FOR THE DIAGNOSIS OF SYSTEMIC MASTOCYTOSIS JUNE 25, 2024, 1:00 PM–2:00 PM ET Webinar presenters ROBYN SCHERBER, M...
Confronting diagnostic gaps in fungal infection
April 2024—The rise in fungal infections in recent years troubles Sean Zhang, MD, PhD, for reasons near and far. It’s readily apparent in the patient populations at Johns Hopkins Hospital, wh...
Hybrid practice model beckons as solution
April 2024—With the technology now available, could and should remote diagnostic pathology, or at least a hybrid model, become more the norm in the future? Timothy Craig Allen, MD, JD, and Case...
Roche pTau217 test gets breakthrough device designation
April 17, 2024—Roche announced that its Elecsys pTau217 assay received breakthrough device designation from the FDA. The post Roche pTau217 test gets breakthrough device designation first ap...
Need for speed in solid tumor molecular testing
April 2024—As the call for fast turnaround of genetic testing results in tumor profiling grows louder, the need for rapid, reliable test methods becomes more pressing. Meanwhile, with new genet...
Microscope to image—big lift but also a blueprint
April 2024—The Food and Drug Administration in February cleared Proscia’s Concentriq AP-Dx digital pathology software for the purpose of primary diagnosis. The post Microscope to image—bi...
Billing headwinds grow stronger for labs
April 2024—In billing for pathology and laboratory services, the hurdles are only getting higher. Narrow networks, prior authorizations, claims denials. Payers “have deeper pockets and figure...
How Duke’s molecular diagnostics lab retains and trains
April 2024—Too few people, too much to do. In that, Duke Health’s molecular diagnostics laboratory is no different from any other laboratory. But competing for staff on the basis of money alo...
AMP case report: Use of molecular techniques to solve a challenging case of primary cutaneous marginal zone lymphoma
April 2024—Primary cutaneous marginal zone lymphoma (PCMZL) is a newly recognized, distinctive subtype of non-Hodgkin’s lymphoma. This low-grade lymphoma predominantly presents as papules or ...
A how-to guide to quality management in clinical labs
CAP Publications released this month its newest book, Quality Management in Clinical Laboratories: Optimizing Patient Care Through Continuous Quality Improvement. It is a second edition; the firs...
Liquid Biopsy and Concurrent Testing Strategies for Patients with Metastatic NSCLC
Webinar presenter ZIN HTWAY, PHD, Supervisor and Operations Manager, Anatomic Pathology as HCA Los Robles Hospital and Medical Center, discusses the impact of liquid biopsy and concurrent biomark...
From the President’s Desk
April 2024—When Tip O’Neill, former speaker of the U.S. House of Representatives, said many years ago that all politics is local, he was talking about how elections, legislation, and all of p...
Newcomer Supply to distribute HistoCyte cell line controls
April 16, 2024—Newcomer Supply announced it is distributing HistoCyte Laboratories cell line controls. The post Newcomer Supply to distribute HistoCyte cell line controls first appeared on...
Clinical pathology selected abstracts
April 2024—Neonatal anemia is a common comorbidity of premature infants and may result from certain obstetric conditions or diseases, or, in the case of iatrogenic anemia, from multiple phlebot...
Anatomic pathology selected abstracts
April 2024—Fumarate hydratase-deficient renal cell carcinoma is a rare and distinct subtype of renal cancer caused by FH gene mutations. FH negativity and s-2-succinocysteine (2SC) positivity o...
Molecular pathology selected abstracts
April 2024—Personalized medicine is revolutionizing cancer therapy, with targeted treatments customized to a person’s cancer-specific mutational profile leading to substantially improved heal...
Newsbytes
April 2024—Transitioning to digital pathology can seem complex and costly. And for some, but not all, laboratories, cost in particular can be a barrier to adoption. So how do you determine whic...
Q&A column
APRIL 2024 Q. Ordering clinicians are requesting that our laboratory flag abnormally high absolute neutrophil counts (ANC) on peritoneal fluids. We cannot find sources for reference ranges, but t...
Put It on the Board
April 2024—Member organizations of the Enduring Consensus Cervical Cancer Screening and Management Guidelines effort released in March their recommendations for the use of p16/Ki-67 dual stain ...
Letters
April 2024—The article “Test adds twists to lung disease diagnosis” (November 2023, page 1) virtually ignores the major problem of clinicians in the hospital thinking that it is perfectly o...
https://www.captodayonline.com/letters-0424/?utm_source=rss&utm_medium=rss&utm_campaign=letters-0424
Roche CDx to ID patients eligible for Enhertu gets CE mark
April 15, 2024—Roche announced it obtained the CE mark for its Ventana HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx to identify metastatic breast cancer patients with low HER2 expression ...
FDA clears Pathfast POC hs-cTnI test
April 12, 2024—Polymedco announced FDA 510(k) clearance of the Pathfast hs-cTnI-II, a high-sensitivity cardiac troponin assay for the diagnosis of myocardial infarction at the point of care. ...
BYG4lab opens U.S. subsidiary in Chicago
April 12, 2024—BYG4lab Group has opened its U.S subsidiary, BYG4lab, in Chicago and appointed Tim Bickley, MLS(ASCP), MBA, CPHIMS, vice president of sales for the U.S. market. The post BYG4la...
Bio-Rad expands availability of Unity Next Peer QC
April 11, 2024—Bio-Rad Laboratories has launched its Unity Next Peer QC data management software in Europe, the Middle East, and Africa. The post Bio-Rad expands availability of Unity Next Pe...
Bosch, Randox invest €150 million in Vivalytic platform
April 10, 2024—Bosch and Randox Laboratories have entered into a strategic partnership in which the two companies will invest around €150 million in joint research, development, and distribut...
Streck launches Protein Plus BCT whole blood collection tube
April 8, 2024—Streck announced the launch of its Protein Plus BCT direct draw whole blood collection tube to provide sample integrity during storage, shipping, and handling of blood samples. ...
Sysmex now selling hemostasis products under its brand
April 5, 2024—Sysmex America announced its plan to sell hemostasis instruments and reagents to laboratories in the United States beginning this month, under the company’s mutual original equi...
Risant Health completes acquisition of Geisinger
April 4, 2024—Risant Health has completed its acquisition of Geisinger, the first health system to join Risant in expanding access to value-based care in communities across the country. The p...
Abbott TBI cartridge cleared for use with whole blood
April 3, 2024—Abbott's i-Stat TBI cartridge has received FDA clearance for use with whole blood, allowing clinicians to help assess patients with suspected concussion at the patient's bedside. ...
SpotFire R/ST panel gets 510(k) clearance, CLIA waiver
April 2, 2024—BioMérieux has received FDA 510(k) clearance and CLIA waiver approval for the BioFire SpotFire Respiratory/Sore Throat (R/ST) panel. The post SpotFire R/ST panel gets 510(k) cl...
FDA approves test to screen for malaria in blood donors
April 1, 2024—Roche announced FDA approval of the Cobas Malaria test, a qualitative in vitro nucleic acid screening test for the direct detection of Plasmodium RNA and DNA in whole blood sample...
Boost Your IHC Workflow and Increase Throughput of Cases
See the impact achieved in real-world customer settings with a holistic approach to tissue staining. Learn more . The post Boost Your IHC Workflow and Increase Throughput of Cases first appear...
Next-gen StatStrip glucose system gets 510(k) clearance
March 29, 2024—Nova Biomedical announced the U.S. launch of its 510(k)-cleared, next-generation StatStrip Glucose Hospital meter system. The post Next-gen StatStrip glucose system gets 510(k)...
StatLab acquires Poly Scientific R&D
March 28, 2024—StatLab Medical Products announced the acquisition of Poly Scientific R&D, a manufacturer and supplier of pathology stains, reagents, and paraffin for anatomic pathology laborato...
Labcorp acquires assets of BioReference lab testing business
March 28, 2024—Labcorp and Opko Health announced they have entered into an agreement for Labcorp to acquire select assets of BioReference Health, a wholly owned subsidiary of Opko, for $237.5 m...
De novo classification granted for plasma cell enrichment kit
March 27, 2024—Stemcell Technologies announced that the FDA has granted de novo classification for its immunomagnetic plasma cell enrichment kit. The post De novo classification granted for p...
Gestalt demos new PathFlow features at USCAP meeting
March 26, 2024—Gestalt Diagnostics announce the launch of its AI Algorithm Evaluator, a new tool within the company’s PathFlow digital pathology platform. The post Gestalt demos new PathFlo...
Bayer, Thermo Fisher to develop NGS CDx assays
March 21, 2024—Bayer and Thermo Fisher Scientific announced that they will develop next-generation sequencing–based companion diagnostic assays to help identify patients who may benefit from ...
FDA clears Avails Medical AST system
March 2024—Avails Medical announced it has received FDA 510(k) clearance for its Equant system, an automated lab inoculation preparation system that consists of a single module instrument that ...
Innovative Lab Solutions welcomes VP of solutions
March 2024—Innovative Lab Solutions announced the appointment of Bridget Ketron as its vice president of solutions. With a focus on enhancing efficiency, boosting cash collections, and ensuring...
Agilent, Incyte collaborate to develop CDx
March 2024—Agilent Technologies announced an agreement with Incyte to develop companion diagnostics in hematology and oncology. The agreement enables Agilent to continue to expand its companion...
Bio-Rad publishes third workbook in QC series
March 2024—Bio-Rad Laboratories has published the third workbook in a P.A.C.E.-approved series designed to provide lab professionals with the training and education needed to maintain reliable ...
Verichem reference materials for creatinine assays
March 2024—The Matrix Plus chemistry reference kit and standalone, ultra-high Matrix Plus level F for the calibration verification testing of creatinine assays by enzymatic and colorimetric met...
Randox releases bladder cancer array
March 2024—Randox has released its female bladder cancer array, designed to help clinicians stratify patients presenting with hematuria. The array detects interleukin-12p70, interleukin-13, mid...
Cepheid gets CLIA waiver for Xpert Xpress MVP
March 2024—Cepheid announced it has received FDA clearance with a CLIA waiver for the Xpert Xpress MVP, a multiplex vaginal panel that can now be performed in near-patient settings. The test is...
Binx, Cardinal Health enter into distribution agreement
March 2024—Binx Health announced it has entered into a national distribution agreement with Cardinal Health to expand access to care with its CLIA-waived, FDA-cleared Binx IO. The molecular poi...
FDA clears EDTA cartridges for SeptiCyte Rapid
March 2024—Immunexpress announced FDA clearance of EDTA blood compatible cartridges for use with the SeptiCyte Rapid test. SeptiCyte Rapid is a sample-to-answer, cartridge-based, host response ...
Roche to acquire LumiraDx’s POC technology
March 2024—Roche has entered into a definitive agreement to acquire select parts of the LumiraDx group related to LumiraDx’s point-of-care technology. The transaction is expected to close by ...
Bruker to acquire EliTechGroup
March 2024—Bruker Corp. has entered into a definitive share purchase agreement to acquire EliTechGroup for €870 million (about $940 million) in cash, excluding EliTech’s clinical chemistry ...
Copan gets third clearance for Colibrí system
March 2024—Copan Diagnostics announced the third FDA 510(k) clearance for its Colibrí automated ID/AST preparation instrument. The in vitro diagnostic specimen preparation system has been clea...
Qiagen Digital Insights launches NGS analysis for somatic cancer
March 2024—Qiagen Digital Insights announced its enhanced CLC Genomics Workbench Premium with LightSpeed technology now supports next-generation sequencing for somatic cancer secondary analysis...
OGT expands NGS operations in the U.K.
March 2024—OGT announced the opening of state-of-the-art facilities in Oxford Technology Park in the U.K. The facilities will drive development of OGT’s SureSeq next-generation sequencing pro...
Game’s afoot in bladder cancer research
March 2024—Like identifying the shift in battle that leads to victory, or the battle that wins the war—let alone declaring a war’s ultimate victor—it’s hard to gauge the whens, ifs, and...
From training to first jobs, can the transition be made easier?
March 2024—Pathology trainees and training programs vary, as do first jobs, but the first year in pathology practice is generally said to be a tough one, largely because of the transition to fu...
In diabetes patients, biomarker use for early-stage HF
March 2024—For patients with type 2 diabetes, the cardiac biomarkers are a better predictor of early-stage heart failure than conventional risk prediction scores. “We need to use biomarkers,�...
Survey probes staff shortage in genomics labs
March 2024—From a technologist workforce perspective, clinical genomics laboratories are in trouble. “It’s truly a crisis,” said Marco Leung, PhD, clinical director of the Steve and Cindy...
AP and CP reporting, from interfaces to IT wishes
March 2024—Anatomic and clinical pathology reporting—what’s working, what’s missing. Three pathologists (all board certified in informatics) and representatives of three information syste...
What’s going on? Interpreting urine toxicology cases
March 2024—For urine toxicology screening, immunoassays are automated and rapid but have variable sensitivity and specificity and results are considered presumptive. Mass spectrometry, used for...
AMP case report: Acute myeloid leukemia with hyperdiploidy
March 2024—CAP TODAY and the Association for Molecular Pathology have teamed up to bring molecular case reports to CAP TODAY readers. AMP members write the reports using clinical cases from the...
In urinalysis, compromises, collections, and rules
March 2024—Reflex criteria, middleware, bladder cancer screening, point of care, controls, and collections came up in CAP TODAY’s Jan. 16 roundtable on urinalysis. Six people weighed in, with...
From the President’s Desk
March 2024—During the 12 years I spent as director of a pathology residency program, one thing I worried about was how to better prepare our residents for their first roles as attending patholo...
Clinical pathology selected abstracts
March 2024—Despite research into colorectal cancer screening and clinical experience, screening uptake remains low. Colorectal cancer (CRC) screening involves noninvasive tests, such as a fecal...
Anatomic pathology selected abstracts
March 2024—Lung transplantation is the definitive therapy for end-stage pulmonary sarcoidosis. While several case reports have described recurrent sarcoidosis in allografts, the incidence and c...
Molecular pathology selected abstracts
March 2024—Human epidermal growth factor receptor 2 is a critical biomarker in breast cancer, gastrointestinal malignancies, and other cancers. HER2 protein expression can be evaluated using IH...
Q&A column
MARCH 2024 Q. Is it a requirement that routine bacteriology cultures (for example, urine, sputum) be plated in a biological safety cabinet in your typical hospital biosafety level 2 laboratory? I...
Newsbytes
March 2024—While Dr. Seuss’ assertion that “the more that you read, the more things you will know” is generally accurate, it doesn’t address the fact that how information is presented a...
Put It on the Board
March 2024—The Food and Drug Administration approved in December the AvertD test, which assesses whether an individual may have an elevated risk of developing opioid use disorder. Its intended ...
Roche debuts Navify solutions at HIMSS24
March 15, 2024—Roche debuted its Navify Analytics for POC and Navify Monitoring solutions at the Healthcare Information and Management Systems Society global health conference in Orlando, March...
Sekisui gets EUA for Osom flu, SARS-CoV-2 test
March 13, 2024—Sekisui Diagnostics received EUA clearance for its Osom Flu SARS-CoV-2 Combo test for use in professional and home testing settings. The post Sekisui gets EUA for Osom flu, SAR...
New ASCCP guidelines now include dual-stain triage testing
March 12, 2024—Roche Diagnostics announced the release of new guidelines from the American Society for Colposcopy and Cervical Pathology and other members of the Enduring Consensus Cervical Ca...
BD Biosciences releases RealBlue reagents
March 2024—BD Biosciences has released its BD Horizon RealBlue 744 and 705 laser-specific reagents, designed to reduce spillover and well suited for low- to medium-expression surface and intrac...
Pramana joins Proscia Ready
March 11, 2024—Proscia announced that Pramana, an artificial intelligence–enabled health technology company, is now a Proscia Ready partner. The post Pramana joins Proscia Ready first appe...
FDA clears Diasorin Liaison Plex system
March 5, 2024—Diasorin announced FDA 510(k) clearance for its Liaison Plex platform and Flex respiratory assay. The post FDA clears Diasorin Liaison Plex system first appeared on CAP TODAY .
Sebia gets FDA clearance for free light chain assays
Sebia announced it has received FDA 510(k) clearance for its free light chain kappa and lambda assays, intended to aid in diagnosing and monitoring patients who have multiple myeloma or immunoglo...
Bruker to acquire EliTechGroup
March 1, 2024—Bruker Corp. has entered into a definitive share purchase agreement to acquire EliTechGroup for €870 million (about $940 million) in cash, excluding EliTech’s clinical chemist...
Combining Clinical Signs and Symptoms with Histopathology f... Diagnosis of Idiopathic Multicentric Castleman Disease (iMCD)
Webinar presenter JADE NEFF, MD, PHD, Assistant Professor of Pathology, Duke University Medical Center, discusses Definitive Diagnosis of Idiopathic Multicentric Castleman Disease (iMCD), includi...
CAP TODAY
Empowering Pathology Partnerships for Growth & Rewards with GoPath Webinar presenters JIM LU, MD, PHD, CEO, Medical Director GoPath Diagnostics, and KENNETH BLOOM, MD, Head of Pathology, Nucle...
Binx enters into distribution agreement with Cardinal Health
Feb. 21 2024—Binx Health announced a national distribution agreement with Cardinal Health to expand access to care with its CLIA-waived, FDA-cleared Binx IO. The post Binx enters into distrib...
Doing more, doing better in bladder cancer
February 2024—From her vantage at the University of Texas MD Anderson Cancer Center, Donna Hansel, MD, PhD, has a clear view of cancer’s latest frontiers. Progress and breakthroughs are the n...
As AI use expands, ethics at the leading edge
February 2024—Artificial intelligence is sizzling, so much so that New Yorker magazine, evoking the dazzling and the potentially devouring nature of AI technology, tagged 2023 as “The Year A....
Biomarker tests with discrepant results—why the differences?
February 2024—When multimodality testing reveals discordant biomarker results, which method is correct? Annette S. Kim, MD, PhD, and JinJuan Yao, MD, PhD, in a CAP23 session last fall used thei...
With pipeline for pathologists, others lacking, eyes on AI
February 2024—Artificial intelligence and Medicare Advantage contracts were at the center of the Jan. 2 Compass Group virtual roundtable led by CAP TODAY publisher Bob McGonnagle. “If you wan...
How we can help pathologists in Ethiopia
February 2024—Ethiopia’s health care system is at a crossroads as it grapples with the dual burden of infectious diseases and a surge in noncommunicable ailments. The post How we can help p...
Group’s pathology aides fill gaps, lighten the workload
February 2024—Efficiency can be hard to measure. But Kenneth Batts, MD, of Hospital Pathology Associates in Minneapolis, which contracts with Allina Health to provide anatomic pathology coverag...
The race to keep pace with drug use changes
February 2024—Xylazine prevalence, lab-developed testing, and new technology are converging at Yale New Haven Health in a way that gives rise to questions, worry, and new hope for faster drug t...
AP and CP reporting—the needs, the caveats
February 2024—Anatomic and clinical pathology reporting—what’s working, what’s missing. Three pathologists (all board certified in informatics) and representatives of three information sy...
From the President’s Desk
February 2024—Even before the pandemic, burnout had become a major issue in medicine. Today, the effects of too much stress, staff shortages, and increasing demands have become so widespread in...
Clinical pathology selected abstracts
February 2024—Patients receiving a pathology report may have many outstanding questions that can cause anxiety and confusion. The 21st Century Cures Act has increased patients’ access to path...
Anatomic pathology selected abstracts
February 2024—The gold standard for prostate cancer diagnosis is the pathological examination of prostate biopsy tissue by light microscopy. The application of artificial intelligence (AI) to d...
Molecular pathology selected abstracts
February 2024—Precision cancer medicine relies heavily on understanding the genomic landscape of tumors. Prior comparisons between African and European ancestry, though based on limited data, h...
Q&A column
FEBURARY 2024 Q. In a case of suspected drug-related death, how specific can an autopsy be in identifying the drug(s) that might have caused the person’s death and the amount of drugs present? ...
Newsbytes
February 2024—The key to using ChatGPT and other large language models effectively in pathology is understanding not only what they are designed to do but, just as importantly, what they are no...
Put It on the Board
February 2024—Members of the CAP Machine Learning Working Group, Informatics Committee, Digital and Computational Pathology Committee, and Council on Informatics and Pathology Innovation have p...
Roche, PathAI to develop AI digital pathology algorithms
Feb. 14, 2024—Roche announced it has entered into an agreement with PathAI to develop AI-enabled digital pathology algorithms for Roche Tissue Diagnostics’ companion diagnostics business. T...
Bio-Rad publishes third workbook in QC series
Feb. 13, 2024—Bio-Rad Laboratories has published its third workbook in a series that offers Professional Acknowledgement for Continuing Education credits. The post Bio-Rad publishes third wor...
Proscia gets FDA 510(k) clearance for Concentriq AP-Dx
Feb. 12, 2024—Proscia has received FDA 510(k) clearance for its Concentriq AP-Dx diagnostic software for primary diagnosis. The post Proscia gets FDA 510(k) clearance for Concentriq AP-Dx fi...
StatLab launches PiSmart slide printer
February 2024—StatLab announced the availability of its PiSmart thermal transfer slide printer for the automated printing of histology slides with patient information in three to five seconds. ...
BioMérieux acquires software company Lumed
Feburary 2024—BioMérieux has acquired the entire share capital of software company Lumed, increasing its stake from 16 to 100 percent. The acquisition of 84 percent of the capital represents a...
Thermo Fisher, Aesku sign distribution agreement
February 2024—Thermo Fisher Scientific announced an exclusive distribution agreement with Aesku Group to market, sell, and support Aesku’s portfolio of FDA-cleared immunofluorescence products...
Horiba launches next-gen HELO hematology solution
February 2024—Horiba Medical has launched the CE-IVDR–approved HELO 2.0 high-throughput automated hematology platform. The platform is composed of the Yumizen H1500 and H2500 high-throughpu...
CLSI introduces country-based pricing model
February 2024—The Clinical and Laboratory Standards Institute has implemented new country-based pricing for countries that meet economic criteria set forth by the World Bank. Under this model, ...
FormaPath, UB CAT announce clinical R&D collaboration
February 2024—FormaPath and the University at Buffalo Center for Advanced Technology in Big Data and Health Sciences (UB CAT) announced their collaboration to further test and develop FormaPath...
Machaon offers updated aHUS genetic panel
February 2024—Machaon Diagnostics has updated its genetic panel for detecting atypical hemolytic uremic syndrome. The aHUS genetic panel 3.0 now includes two more genes, for a total of 22, asso...
Verichem bilirubin, urine chemistry reference materials
February 2024—Verichem Laboratories now offers its Tru-Zero Bilirubin Standard as part of the company’s line of liquid-stable and protein-based total and direct bilirubin clinical reference m...
Sekisui, Aptitude partner to provide POC COVID test
February 2024—Sekisui Diagnostics formalized an exclusive distribution agreement with Aptitude Medical Systems to sell the Aptitude Metrix COVID-19 test in the United States. The EUA-approved, ...
New chapter in digital pathology
February 2024—Advancements in whole slide imaging, integration of AI, and global collaboration networks are three areas the new president of the Digital Pathology Association highlighted in his...
Flagship, Offspring partner to provide assay development services
February 2024—Flagship Biosciences and Offspring Biosciences announced a strategic partnership to provide a comprehensive suite of preclinical and clinical services. The partnership allows the ...
Qiagen STI assay cleared for use on NeuMoDx systems
February 2024—Qiagen announced FDA clearance of the NeuMoDx CT/NG assay 2.0 for its NeuMoDx 96 and 288 integrated PCR-based clinical molecular testing systems in the United States. The assay is...
Roche launches next-generation qPCR system
February 2024—Roche launched the LightCycler Pro system, designed and labeled for research and in vitro diagnostic workflows. Enhancements of this LightCycler system include a new vapor chamber...
Fujirebio introduces pTau 217 plasma assay
February 2024—Fujirebio announced the availability of its Lumipulse G pTau 217 plasma assay for the fully automated Lumipulse G immunoassay systems. The chemiluminescent enzyme immunoassay prov...
TechLab test detects C. difficile infection
February 2024—TechLab’s C. Diff Quik Chek Complete test is a rapid membrane enzyme immunoassay for the simultaneous detection of Clostridium difficile glutamate dehydrogenase antigen and toxi...
Health Canada approves Corista DP3 platform
Feb. 7, 2024—Corista announced it has received a class II medical device license from Health Canada for its DP3 platform, a web-based image-management system for digital pathology. The post H...
CellaVision, Sysmex sign strategic alliance agreement
Feb. 6, 2024—CellaVision and Sysmex announced a strategic alliance agreement that expands their mutual commitment until 2038. The post CellaVision, Sysmex sign strategic alliance agreement f...
Beckman Coulter unveils DxC 500 AU chemistry analyzer
Feb. 5, 2024—Beckman Coulter Diagnostics unveiled its DxC 500 AU chemistry analyzer today at Medlab Middle East in Dubai. The post Beckman Coulter unveils DxC 500 AU chemistry analyzer first...
FDA clears Hologic Genius digital cytology system
Feb. 2, 2024—Hologic announced that its Genius Digital Diagnostics system with the Genius Cervical AI algorithm has received clearance from the FDA, making it the first FDA-cleared digital cyto...
Epredia Announces Launch of SlideMate Laser
SlideMate Laser is the latest addition to Epredia’s world-class portfolio of precision cancer diagnostics products and services that provide a seamless end-to-end laboratory workflow. SlideMate...
iSpecimen, TriMetis partner to enhance tissue-based research
Jan. 24, 2024—The company iSpecimen, an online marketplace that connects life science researchers seeking human biospecimens for medical research with health care organizations that have such s...
FDA approves treatment for rare blood clotting disorder
January 2024—The Food and Drug Administration approved Adzynma (Takeda Pharmaceuticals), the first recombinant protein product indicated for prophylactic or on-demand enzyme replacement therapy...
Smart In Media launches grossing camera and software
January 2024—Smart In Media announced the release of its PathoZoom LiveView Macro camera and PathoZoom software. The post Smart In Media launches grossing camera and software first appeared ...
OGT, Intelliseq launch NGS reporting for myeloid malignancy panels
January 2024—OGT and Intelliseq released GeneSpect Somatic Reporter for use with OGT’s SureSeq portfolio of next-generation sequencing panels, including SureSeq myeloid panels. The post OGT...
FDA clears MeMed BV test for use on whole blood
January 2024—MeMed announced that the FDA has granted 510(k) clearance for the company’s MeMed BV test for use on whole blood samples on the MeMed Key analyzer. The post FDA clears MeMed ...
Genomadix Cube cleared for CYP2C19 testing
January 2024—The Genomadix Cube CYP2C19 system is a PCR-based test that provides genotyping results of the *2, *3, and *17 alleles of the CYP2C19 gene from a buccal swab sample in one hour. T...
FormaPath launches AdiPress for lymph node dissection
January 2024—FormaPath announced the commercial launch of AdiPress, an automated tool to standardize lymph node dissection. The post FormaPath launches AdiPress for lymph node dissection fir...
Cepheid gets CLIA waiver for Xpert Xpress MVP
Jan. 19, 2024—Cepheid announced it has received FDA clearance with a CLIA waiver for the Xpert Xpress MVP, a multiplex vaginal panel that can now be performed in near-patient settings. The po...
More progress, fewer barriers for PGx testing
January 2024—Sometimes even superb ideas can also turn out to be quite, well, bothersome. Zoom meetings. Bridal showers. Bike lanes. Parking apps. QR menu codes. And—if laboratories aren’t ...
The who, when, and why of thrombophilia testing
January 2024—Thrombophilia testing has been shown to be performed far more often than indicated in thromboembolic events, at significant cost to the patient and hospital. The post The who, wh...
Lab-developed test proposal reflections and predictions
January 2024—The Food and Drug Administration’s proposed rule on laboratory-developed tests would phase out its existing enforcement discretion approach for oversight of LDTs. Instead, the FD...
A scan of studies on HER2-low breast cancer scoring
January 2024—Much has been said and written about scoring HER2-low breast cancer, and it has its difficulties. But there are steps and tools to support scoring, and Savitri Krishnamurthy, MD, l...
7 pointers for POC cardiac troponin measurement
January 2024—Seven recommendations for the use of cardiac troponin measurement at the point of care were published last year and reported in a session at the Association for Diagnostics and Lab...
Thoracic SMARCA4-deficient undifferentiated tumor
January 2024—Thoracic SMARCA4-deficient undifferentiated tumor (TSDUT), formerly known as SMARCA4-deficient thoracic sarcoma and SMARCA4-deficient thoracic sarcomatoid tumor, is a relatively ne...
Bethesda System for Reporting Thyroid Cytopathology
January 2024—The Bethesda System for Reporting Thyroid Cytopathology (TBSRTC) is a widely endorsed and globally adapted standardized reporting system of thyroid fine-needle aspiration specimens...
Reporting urine cytology: how Paris 2.0 differs from 1.0
January 2024—Urinary cytology is widely used to screen for high-grade urothelial carcinoma (HGUC) and to monitor for recurrence. Several reporting systems have been proposed over the past few d...
Panelists on viscoelastic and other coag assays
January 2024—Viscoelastic assays and other coagulation tests were front and center when CAP TODAY publisher Bob McGonnagle on Nov. 20 convened seven people in an online roundtable. Oksana Volod...
From the President’s Desk
January 2024—I was planning to write about a much more pleasant topic this month, but instead I’ll use this column to address something that’s gnawing at all of us now: the prospect of FDA ...
Clinical pathology selected abstracts
January 2024—People respond differently to SARS-CoV-2 infection, with some having a very severe clinical course and sequelae while others recover quickly. Several research studies have used lab...
Anatomic pathology selected abstracts
January 2024—Diffuse parenchymal lung disease is a well-recognized complication of systemic connective tissue disease but rarely arises in patients with psoriasis or psoriatic arthritis, which ...
Molecular pathology selected abstracts
January 2024—DDX41 is involved in multiple cellular processes, including RNA metabolism and splicing. Inherited variants have been linked to an increased risk of the blood neoplasms myelodyspla...
Q&A column
JANUARY 2024 Q. Can a person who has a bachelor of science degree in health care administration sign off on competency assessments? Read answer . Q. Our laboratory uses a total protein assay fr...
Newsbytes
January 2024—When the medical microbiology laboratory at Yale-New Haven Hospital makes operational changes, it uses data analytics to monitor their impact. Yet the process of implementing labor...
Put It on the Board
January 2024—The Association for Molecular Pathology on Dec. 14 published a joint report on what to consider for a slice testing strategy for diagnostics, including gene selection, analytic per...
Biocare Medical unveils IntelliPath+ staining instrument
January 2024—Biocare Medical has introduced the IntelliPath+ advanced staining instrument, intended for in vitro diagnostic use and redesigned with input from users and the latest technologic...
FDA clears BD MiniDraw capillary blood collection system
January 2024—BD announced it has received FDA 510(k) clearances for its BD MiniDraw, a novel blood collection device that obtains blood samples from a fingerstick. The clearances include low-vo...
CLSI releases jointly developed 2023 breakpoint implementation toolkit
January 2024—The Clinical and Laboratory Standards Institute, Association of Public Health Laboratories, American Society for Microbiology, the CAP, and Centers for Disease Control and Preventi...
FDA clears QuidelOrtho Savanna PCR platform and HSV 1+2/VZV assay
January 2024—QuidelOrtho has received FDA 510(k) clearance for its Savanna PCR platform and Savanna HSV 1+2/VZV in vitro diagnostic test for the detection and differentiation of herpes simplex ...
Roche launches Elecsys HBeAg quant in CE markets
January 2024—Roche launched the Elecsys HBeAg quant, an immunoassay for the in vitro qualitative and quantitative determination of hepatitis B e antigen in human serum and plasma. In conjunctio...
Ad Astra QScout hematology analyzer gets 510(k) clearance
January 2024—Ad Astra Diagnostics has received 510(k) clearance from the FDA for its QScout rapid-result hematology system. The analyzer provides point-of-care white blood cell counts and a ne...
Tosoh G8 now connects to Sysmex XN-9000, XN-9100 systems
January 2024—Tosoh Bioscience has entered into an agreement with Sysmex America in which its HLC-723G8 automated glycohemoglobin analyzers can be connected to Sysmex XN-9000 and XN-9100 automat...
BioMérieux acquires software company Lumed
Jan. 11, 2024—BioMérieux has acquired the entire share capital of software company Lumed, increasing its stake from 16 to 100 percent. The post BioMérieux acquires software company Lumed f...
Horiba Medical launches next-gen HELO hematology solution
Jan. 9, 2024—Horiba Medical has launched the CE-IVDR-approved HELO 2.0 high-throughput automated hematology platform. The post Horiba Medical launches next-gen HELO hematology solution first...
New chapter in digital pathology
Jan. 8, 2024—Advancements in whole slide imaging, integration of AI, and global collaboration networks are three areas the new president of the Digital Pathology Association highlighted in his ...
Sekisui, Aptitude partner to provide POC COVID test
Jan. 4, 2024—Sekisui Diagnostics formalized an exclusive distribution agreement with Aptitude Medical Systems to sell the Aptitude Metrix COVID-19 test in the United States. The post Sekisui,...
FormaPath, UB CAT announce clinical R&D collaboration
Jan. 4, 2024—FormaPath and the University at Buffalo Center for Advanced Technology in Big Data and Health Sciences (UB CAT) announced their collaboration to further test and develop FormaPath�...
Roche to acquire LumiraDx’s POC technology
Jan. 2, 2024—Roche announced it has entered into a definitive agreement to acquire LumiraDx’s point-of-care technology platform business, which offers a range of immunoassay and clinical chem...
Quest, Scipher partner to expand testing for patients with RA
December 2023—Quest Diagnostics and Scipher Medicine announced a collaboration designed to expand patient access to diagnostic services for rheumatoid arthritis. Under a multiyear collaboration...
FDA authorizes Invitae panel for common hereditary cancers
December 2023—The FDA has granted de novo marketing authorization for the Invitae Common Hereditary Cancers panel, an in vitro diagnostic test that can help detect hundreds of genetic variants ...
BD launches next-gen blood draw technology
December 2023—BD launched its FDA 510(k)–cleared Pivo Pro needle-free blood collection device, which is compatible with integrated and long peripheral IV catheters, including the Nexiva close...
TriVerity gets FDA breakthrough device designation
December 2023—Inflammatix announced that the FDA has granted breakthrough device designation to its TriVerity acute infection and sepsis test system. The system, which is currently under develo...
Cardiac Advance now compatible with Beckman instruments
December 2023—Bio-Rad Laboratories has announced the expanded compatibility of its cardiac control, Cardiac Advance, to include Beckman Coulter instruments. The next-generation control is optim...
OGT, Intelliseq partner to advance clinical insight from NGS data
December 2023—OGT announced a partnership with Intelliseq, a genome informatics company and provider of next-generation sequencing analysis solutions. The collaboration combines OGT’s SureSeq...
Mayo, Progentec to market biomarker tests for autoimmune diseases
December 2023—Mayo Clinic Laboratories announced a strategic collaboration to bring Progentec’s proprietary biomarker blood tests for the management of autoimmune diseases to market. The coll...
LGC launches unmethylated, methylated ctDNA mutation mixes
December 2023—LGC Clinical Diagnostics has launched Seraseq unmethylated and methylated ctDNA mutation mixes for assay development, validation, and routine performance monitoring. Key features ...
Veracyte announces IVD agreement with Illumina
December 2023—Veracyte has entered into a multiyear agreement with Illumina to develop and offer some of its high-performing molecular tests as decentralized in vitro diagnostic tests on Illumi...
Revvity study shows value of NGS in newborn screening
December 2023—A recent study by Revvity Omics has shown the clinical value of proactive, sequencing-based screening in apparently healthy newborns (Balciuniene J, et al. JAMA Netw Open. 2023;6:...
FoundationOne CDx approved for capivasertib plus fulvestrant
December 2023—Foundation Medicine has received FDA approval for its FoundationOne CDx to be used as a companion diagnostic for capivasertib (Truqap, AstraZeneca) in combination with fulvestrant...
FDA approves therapy for myelodysplastic syndromes
December 2023—The FDA has approved ivosidenib (Tibsovo, Servier Pharmaceuticals) for the treatment of adult patients with relapsed or refractory myelodysplastic syndromes with an isocitrate deh...
Tosoh G8 now connects to Sysmex XN-9000, XN-9100 systems
Dec. 27, 2023—Tosoh Bioscience has entered into an agreement with Sysmex America in which its HLC-723G8 automated glycohemoglobin analyzers can now be connected to Sysmex XN-9000 and XN-9100 au...
FDA clears QuidelOrtho Savanna platform, HSV 1+2/VZV assay
Dec. 21, 2023—QuidelOrtho has received FDA 510(k) clearance for its Savanna PCR platform and Savanna HSV 1+2/VZV in vitro diagnostic test for the detection and differentiation of herpes simplex...
And the band neutrophil counts play on
December 2023—The recent CAP proficiency testing questionnaire was meant to be the coup de grâce. Hematology PT participants were asked about their band neutrophil reporting practices and, giv...
Corista DP3 platform gets CE IVD mark
Dec. 14, 2023—Corista announced today that its DP3 platform has been certified with the CE in vitro diagnostic mark for routine diagnosis in the European Union and United Kingdom. The post Co...
In fee schedule final rule, lower cuts than proposed
December 2023—In the 2024 Medicare physician fee schedule final rule, the Centers for Medicare and Medicaid Services reacted favorably to the CAP’s advocacy to mitigate payment decreases to p...
New guidance on lab analysis in diabetes
December 2023—The third and latest edition of recommendations for laboratory analysis in diagnosing and managing diabetes mellitus, released this summer, provide guidance on, among other things...
In ED/urgent cares, the lab tests and the POC team
December 2023—A point-of-care testing team from TriCore was part of standing up three dual emergency department/urgent care centers in as many years, with a fourth set to open in March 2024. �...
Study of suspected transfusion reactions to begin Jan. 1
A new CAP Quality Practices study on rates and turnaround times for investigating and reporting suspected transfusion reactions will begin on Jan. 1, 2024. Enrollment is open now and will contin...
Savings follow allergy, autoimmune test consolidation
December 2023—Hoi-Ying Elsie Yu, PhD, D(ABCC), isn’t new to workflow optimization. As system director of chemistry, point-of-care testing, and preanalytics for Geisinger Medical Center in Dan...
Digital pathology and AI—drivers, budgets, and jobs
December 2023—Digital pathology and AI—the push, the potential, the changing questions, the reimbursement, and the caution. All that and more came up when CAP TODAY publisher Bob McGonnagle o...
Phlebotomy program gives lift to lab, community
December 2023—The clinical laboratory at Children’s Hospital of Philadelphia is solving two problems at once: its phlebotomist staffing shortage and the need for some in its community to lear...
LDT proposal on the radar—little detail, clarity needed
December 2023—For most, laboratory staffing woes continue, despite some letup post-pandemic. CAP TODAY publisher Bob McGonnagle on Nov. 7 got a sampling of where staffing stands as the year end...
AMP case report: Potential von Hippel-Lindau syndrome in a patient with negative germline testing
CAP TODAY and the Association for Molecular Pathology have teamed up to bring molecular case reports to CAP TODAY readers. AMP members write the reports using clinical cases from their own practi...
From the President’s Desk
December 2023—About five years ago, when I was serving in my first term on the CAP Board of Governors, I attended a House of Delegates meeting where we had a candidate forum with several people...
Anatomic pathology selected abstracts
December 2023—Cytomegalovirus hepatitis in allograft livers is a significant infectious complication for which the histology historically has been described as overlapping that of acute cellula...
Clinical pathology selected abstracts
December 2023—Efforts to develop biomarkers that help predict risk factors for preeclampsia/eclampsia and to better understand the trends and implications related to new-onset hypertensive diso...
Molecular pathology selected abstracts
December 2023—Immune checkpoint blockade therapy has dramatically altered treatment options for a variety of cancers. A high tumor mutation burden (TMB) is considered one of the strongest predi...
Q&A column
DECEMBER 2023 Q. When using a sodium citrate blue-top tube due to platelet clumping, should the sample be kept warm, and does it have to be run within a certain time frame? Read answer . Q. Doe...
Newsbytes
December 2023—While many dismiss the saying “Nothing lasts forever” with a simple shrug, those three words may cause angst in those anticipating the demise of their laboratory information s...
Put It on the Board
December 2023—The Food and Drug Administration granted approval for EntroGen’s CRCdx RAS Mutation Detection Kit as a companion diagnostic for Vectibix (panitumumab), used in the treatment of ...
In memoriam
John Kelly Duckworth, MD 1928–2023 December 2023—John Kelly Duckworth, MD, a member of the CAP Board of Governors from 1987 to 1993, died on Sept. 14 at age 95. Dr. Duckworth was the second c...
CLSI releases breakpoint implementation toolkit
Dec. 12, 2023—The Clinical and Laboratory Standards Institute, Association of Public Health Laboratories, American Society for Microbiology, the CAP, and Centers for Disease Control and Prevent...
Smart In Media launches grossing camera and software
Dec. 7, 2023—Smart In Media announced the release of its PathoZoom LiveView Macro camera and PathoZoom software. The post Smart In Media launches grossing camera and software first appeared ...
Implementation of an FDA-cleared tumor profiling assay to enable localized Precision Oncology testing for patients
Webinar presenters ALEXANDER CRAIG MACKINNON, JR, MD, PHD, Professor, Department of Pathology, University of Alabama at Birmingham, DARSHAN CHANDRASHEKAR, PHD, Assistant Professor, Department of ...
CellNetix selects Proscia for digital pathology
Dec. 6, 2023—CellNetix Pathology and Laboratories and Proscia announced today that CellNetix has selected Proscia to digitize a portion of its volume of 1 million glass slides scanned per year....
Spire partners with Tribun to advance pathology services
Dec. 5, 2023—Spire Healthcare, through its partnership with the Paris-based digital pathology company Tribun Health, announced its plans to launch its new digital infrastructure and services ea...
FormaPath launches AdiPress for lymph node dissection
Nov. 29, 2023—FormaPath announced the commercial launch of AdiPress, an automated tool to standardize lymph node dissection. The post FormaPath launches AdiPress for lymph node dissection fi...
Paige, Nuance to create largest pathology consult network
Nov. 27, 2023—Paige announced it has teamed up with Nuance, a Microsoft company, to create the largest digital consultation network in pathology. By merging Paige’s digital pathology tools, s...
EntroGen gets PMA for CRCdx RAS mutation detection kit
Nov. 21, 2023—The FDA has granted approval for EntroGen’s CRCdx RAS mutation detection kit as a companion diagnostic for Vectibix (panitumumab). The post EntroGen gets PMA for CRCdx RAS mut...
Verichem reference materials for serum and urine testing
November 2023—Verichem Laboratories announced the availability of its Urine Uric Acid Standard kit, Matrix Plus Cholesterol Reference kit, and a standalone, ultra-high Matrix Plus Cholesterol R...
FDA clears Nova Prime Plus for microcapillary sample mode
November 2023—Nova Biomedical announced that the FDA has granted 510(k) clearance for a microcapillary sample mode on the company’s Stat Profile Prime Plus critical care blood gas analyzer. ...
Bio SB launches TintoStainer Plus automatic IHC stainer
November 2023—Bio SB has launched a fully automated immunohistochemistry platform for deparaffinization and antigen retrieval and staining. Applications include immunohistochemistry, Mohs IHC, ...
BioMérieux announces CE mark for Vidas TBI test
November 2023—BioMérieux announced it has received the CE mark for its Vidas TBI (GFAP, UCH-L1), a test to support the assessment of patients who have mild traumatic brain injury. The blood te...
LGC acquires Kova International
November 2023—LGC Clinical Diagnostics announced the acquisition of Kova International, a developer and manufacturer of in vitro urinalysis and toxicology quality control products for clinical ...
FDA clears Thermo Fisher chromogranin A assay
November 2023—Thermo Fisher Scientific announced FDA clearance of its Thermo Scientific Brahms CgA II Kryptor, an automated immunofluorescent assay for the quantitative determination of the con...
FloBio bleeding risk Dx gets FDA breakthrough device designation
November 2023—FloBio announced that the FDA has granted breakthrough device designation for its rapid bleeding risk diagnostic test. The point-of-care test is designed for in vitro diagnostic u...
FDA approves Qiagen CDx for GIST
November 2023—Qiagen announced FDA approval of its Therascreen PDGFRA RGQ PCR kit, a companion diagnostic intended for use to aid clinicians in identifying patients with gastrointestinal stroma...
FDA clears Aptiva Connective Tissue Disease Essential reagent
November 2023—Werfen announced FDA 510(k) clearance of its Aptiva Connective Tissue Disease Essential reagent, to aid in diagnosing connective tissue disease. The Aptiva CTD Essential complemen...
HemoSonics Quantra awarded Innovative Technology contract
November 2023—HemoSonics announced that its Quantra hemostasis system received an Innovative Technology contract award from Vizient. The Quantra system consists of the Quantra hemostasis analyz...
Test adds twists to lung disease diagnosis
November 2023—It was a mystery, wrapped less in an enigma than a few layers of bafflement, surprise, and mild irritation. Call it the Case of the Split Lung Specimens. The first hint something ...
New guidance in checklist on AMR and mass spec
November 2023—In the 2023 edition of the CAP accreditation program checklists is new guidance on analytical measurement range verification and new and revised requirements for mass spectrometry...
Point-of-care testing scorecard spotlights hits and misses
November 2023—At the point of care, there are testing wins, some losses, and plenty of pitfalls. “Point-of-care coordinators all have the same problems,” says Meaghan Gladstone, application...
In some settings, alternatives to HbA1c acceptable
November 2023—Glycated albumin and fructosamine are highly specific, with high levels suggesting hyperglycemia. This points to their utility in monitoring glycemic control in people with diabet...
Generative AI, from education to corner cases
Generative artificial intelligence—what it is, how it can be used in pathology, what stands in its way, why the excitement. CAP TODAY publisher Bob McGonnagle spoke about that and more with pat...
AI-driven spatial biology: the next next-gen sequencing
November 2023—Spatial biology may be an emerging field, but Kenneth Bloom, MD, says he and other pathologists have been doing it “since we got the microscope.” And he argues it’s going to...
Minds shift on digital path, ‘massive change’ predicted
Is digital pathology on the move? Two who know it well say it is. Esther Abels, a precision medicine and biomedical regulatory health science expert who is CEO of SolarisRTC and former president ...
Pathology navigators bring molecular test efficiencies
November 2023—Few things in the laboratory can do so much at once: boost histotechnologist productivity, safeguard tissue, offer a career path and help retain staff, keep watch on test utilizat...
Reports revisited—panel on preferences and pain points
November 2023—Reports—integrated or otherwise—were up for discussion when CAP TODAY publisher Bob McGonnagle convened online in October a group of informatics experts, who spoke of the need...
From the President’s Desk
November 2023—For 100 years, pathologists have been called “the doctor’s doctor.” We have traditionally done our work in the background, interacting mostly with other physicians and not v...
Clinical pathology selected abstracts
November 2023—Among the many reasons unnecessary laboratory tests are ordered in a hospital are preselected orders on order sets, clinician habits, and trainee concerns. Laboratory tests are am...
Anatomic pathology selected abstracts
November 2023—Claudin-4 is a sensitive and specific marker for carcinoma in effusion cytology. The authors examined the diagnostic use of claudin-4 versus MOC-31 and Ber-EP4 by comparing their ...
Molecular pathology selected abstracts
November 2023—Dilated cardiomyopathy is characterized by dilation and weakening of one or both ventricles combined with impaired contractility. Although several external etiologies are associat...
Q&A column
NOVEMBER 2023 Q. A molecular laboratory received an order from an oncologist for next-generation sequencing testing. The patient’s tissue sample was in the custody of a different laboratory, wh...
Newsbytes
November 2023—“The best way to have a good idea is to have a lot of ideas,” according to Linus Pauling, a chemist and chemical engineer who, among other accomplishments, helped create a for...
Put It on the Board
November 2023—Roche announced last month the U.S. launch of its Cobas Connection Modules (CCM) Vertical, the elevator and overhead components of its fully automated and modular CCM system to he...
LGC launches unmethylated and methylated ctDNA mixes
Nov. 16, 2023—LGC Clinical Diagnostics has launched Seraseq unmethylated and methylated ctDNA mutation mixes for assay development, validation, and routine performance monitoring. The post LG...
Amplify the value of your AP LIS
Now available from NovoPath and PathAI is a free webinar that aims to help viewers understand how digital pathology and AI can help an organization. Speakers Eric Walk, MD, Jim Sweeney, and R. Sh...
Leica adds software features to Aperio GT 450 scanner
Nov. 13, 2023—Leica Biosystems has released three software features that aim to improve image quality and flexible scanning solutions in research settings for its Aperio GT 450 digital patholog...
Diagnostic Stewardship in Acute Infectious Gastroenteritis: What Can Real-World Data Tell Us?
Webinar presenter FERRIC C. FANG, MD, discusses the relationship between diagnostic test method and clinical outcomes, challenges in diagnostic testing for acute infectious gastroenteritis, how r...
Elecsys NfL test granted FDA breakthrough device designation
Nov. 10, 2023—Roche announced that its Elecsys neurofilament light chain test for multiple sclerosis received breakthrough device designation from the FDA. The post Elecsys NfL test granted F...
Paige Lymph Node gets FDA breakthrough device designation
Nov. 7, 2023—Paige announced that the FDA has granted breakthrough device designation for Paige Lymph Node, an AI application used to detect breast cancer metastases in lymph node tissue. The...
Roche gets FDA approval for HPV test on Cobas 5800 system
Nov. 6, 2023—Roche announced that the FDA has approved the Cobas HPV test for use on its next-generation Cobas 5800 molecular instrument. The post Roche gets FDA approval for HPV test on Coba...
FDA approves Abbott HPV test to run on Alinity m
Nov. 3, 2023—Abbott has received FDA approval for its molecular human papillomavirus screening test to run on its Alinity m system. The post FDA approves Abbott HPV test to run on Alinity m ...
Bio-Rad cardiac control compatible with Beckman analyzers
Nov. 2, 2023—Bio-Rad Laboratories has announced the expanded compatibility of its cardiac control, Cardiac Advance, to include Beckman Coulter instruments. The post Bio-Rad cardiac control co...
Feasibililty study results evaluating Mainz advanced adenoma biomarkers
October 2023—Mainz Biomed announced results of an independent feasibility study conducted in collaboration with members of the National Cancer Institute’s Early Detection Research Network to ...
Digital path’s star rises from the mists
October 2023—In living up to its promise as a new technology that will revolutionize clinical care through greater ease, speed, and accuracy of diagnosis, digital pathology has been sluggish. W...
Looking ahead to respiratory virus season
October 2023—With respiratory virus season near, those with a close eye on it in August gave the lay of the land for test algorithms, technologies, and forecasts, even as SARS-CoV-2 and RSV cas...
Soon to be required: current susceptibility testing breakpoints
October 2023—A CAP accreditation program requirement that microbiology laboratories use current antimicrobial susceptibility testing breakpoints, which was added to the checklist in 2021, will ...
Inside lab’s experience with assays for Alzheimer’s
October 2023—Orders for cerebrospinal fluid testing for Alzheimer’s disease have grown at Mayo Clinic since spring 2020, when testing was first offered. When aducanumab was approved in May 20...
Fast or comprehensive? Lab offers both for NSCLC
October 2023—For molecular testing in oncology, the choice is often fast or slow. PCR-based platforms are rapid, and comprehensive genomic profiling by next-generation sequencing is slower, and...
New guide to whole blood viscoelastic assays: hemostasis, testing, cases, and applications
October 2023—New this month from CAP Publications is Whole Blood Viscoelastic Assays in Clinical Diagnosis: An Illustrated Case-Based Guide. Viscoelastic testing was designed to determine the c...
AMP case report: Identification of multiple germline cancer... variants in a single patient during tumor sequencing analysis
October 2023—Next-generation sequencing of tumor tissue has important implications in solid and hematologic malignancies because it can identify genomic variants that provide diagnostic, progno...
In hematology, making the most of automated solutions
October 2023—Hematology analyzers and the related workflow, expertise, efficiency, and IT matters were the topic of a roundtable when CAP TODAY publisher Bob McGonnagle met online Aug. 29 with ...
From the President’s Desk
October 2023—In my long career, I’ve met a lot of pathologists. The military pathologist. The private practice pathologist who drives 75 miles each way to serve patients at a small rural hosp...
Clinical pathology selected abstracts
October 2023—Several large randomized controlled trials have shown the safety of tolerating hemoglobin levels as low as 7 g/dL in critically ill hemodynamically stable children. These trials ha...
Anatomic pathology selected abstracts
October 2023—Special AT-rich sequence-binding protein 2, or SATB2, induces local chromatin loops to facilitate transcription. SATB2 immunostaining is commonly used as a marker for colorectal ad...
Molecular pathology selected abstracts
October 2023—Ovarian cancer is the eighth most common cancer in women. There are several histological types of ovarian neoplasms, and all rank among the deadliest gynecological cancers. However...
Q&A column
OCTOBER 2023 Q. What is the total allowable error for lupus anticoagulant testing? Read answer . Q. Our laboratory may relocate to a building five blocks from our current hospital. What kind of i...
Newsbytes
Ocotber 2023—Health care technology companies, by and large, are eager to share product metrics—that is, standalone product performance—with potential pathology lab clients but less eager t...
Put It on the Board
October 2023—The Food and Drug Administration has granted clearance to Streck’s MDx-Chex for BC-GP and MDx-Chex for BC-GN for use in diagnostic procedures. They are quality controls designed ...
In memoriam
October 2023—Thomas Dermott Trainer, MD, a member of the CAP Board of Governors from 1994 to 2000 and secretary-treasurer from 1999 to 2000, died on June 10 at age 94. The post In memoriam f...
MMQCI releases BCR-ABL IS linearity panel
October 2023—Now available from Maine Molecular Quality Controls is the Xpert BCR-ABL IS p210 Linearity Panel C207. It’s intended for use as an assayed external quality control to monitor the...
Parasitology, infectious Dx company Eiger launches
October 2023—Eiger Diagnostics has been formed to provide high-quality parasitology and infectious disease diagnostics worldwide. Eiger’s first product releases are parasitology serology IgG ...
Pillar Biosciences launches OncoReveal Core LBx NGS kit
October 2023—Pillar Biosciences announced the global launch of OncoReveal Core LBx, a research use only, liquid biopsy–based next-generation sequencing kit for pan-cancer tumor profiling. The...
FDA approves Bosulif for pediatric patients with CML
October 2023—The FDA approved bosutinib (Bosulif, Pfizer) for pediatric patients who are one year old and older with chronic phase Ph+ chronic myelogenous leukemia that is newly diagnosed or re...
FDA clears PixCell HemoScreen for direct capillary sampling
October 2023—PixCell Medical announced that the FDA has granted 510(k) clearance for direct capillary sampling with the HemoScreen 5-part differential CBC analyzer. The clearance enables collec...
Wren Labs molecular Dx predicts patient response to PRRT
October 2023—Wren Laboratories launched its PRRT (peptide receptor radionuclide therapy) Predictor Quotient, or PPQ, a companion diagnostic to its NETest, a liquid-biopsy neuroendocrine tumor d...
Primera unveils Signature EVO slide and cassette printers
October 2023—Primera Technology has launched its next-generation Signature EVO slide printer and Signature EVO cassette printer. The post Primera unveils Signature EVO slide and cassette prin...
Sophia Genetics expands relationship with Gustave Roussy
October 2023—Sophia Genetics announced the expansion of its relationship with Gustave Roussy in which the cancer center will use the Sophia DDM digital analytics platform for all relevant sampl...
Verichem enzyme calibration verifiers for liver function testing
October 2023—Verichem Laboratories offers multilevel enzyme calibration verification materials for liver function testing as part of its liquid-stable Enzyme ER Verifier kit. The kit contains t...
FDA clears Alinity h-series hematology system
October 2023—Abbott has received FDA clearance for its Alinity h-series hematology system, which includes the Alinity hq, an automated hematology analyzer, and Alinity hs, an integrated slide m...
Visiopharm, Boston Cell Standards to develop IHC technology
October 2023—Visiopharm and Boston Cell Standards announced they are partnering to integrate immunohistochemistry calibration standards with image analysis software for quality assurance. The j...
Roche launches vertical transportation for patient lab samples
Oct. 18, 2023—Roche announced the U.S. launch of its Cobas Connection Modules Vertical, designed to help low-, mid-, and high-volume laboratories optimize space, productivity, and patient care....
BioMérieux announces CE mark for Vidas TBI test
Oct. 17, 2023—BioMérieux announced it has received the CE mark for its Vidas TBI (GFAP, UCH-L1), a test to support the assessment of patients who have mild traumatic brain injury. The blood te...
Test GTxcel GAM
Pathology/Laboratory Medicine/Laboratory Management
OGT, Intelliseq partner to provide NGS analysis and reporting
Oct. 12, 2023—OGT announced a partnership with Intelliseq, a genome informatics company and provider of next-generation sequencing analysis solutions. The post OGT, Intelliseq partner to prov...
Bio SB launches TintoStainer Plus automatic IHC stainer
Oct. 9, 2023—Bio SB has launched a fully automated immunohistochemistry platform for deparaffinization and antigen retrieval and staining. The post Bio SB launches TintoStainer Plus automatic...
Post-Transplant Viral Infections: Challenges with Clinical Management
Webinar presenters ELENA BEAM, MD, and JOSEPH YAO, MD, discuss the need for standardization in post-transplant diagnostics with emphasis on Epstein-Barr virus (EBV), BK virus (BKV), and CMV. Th...
mTuitive introduces Insight database
Oct. 6, 2023—MTuitive has introduced its mTuitive Insight, a consolidated database designed to give a comprehensive view of cancer data and tie together structured data from any health care IT ...
FDA clears Nova Prime Plus for microcapillary sample mode
Oct. 5, 2023—Nova Biomedical announced that the FDA has granted 510(k) clearance for a microcapillary sample mode on the company’s Stat Profile Prime Plus critical care blood gas analyzer. It...
Illumina, Pillar Biosciences announce partnership
September 2023—Illumina and Pillar Biosciences announced a strategic partnership to make Pillar’s suite of oncology assays commercially available worldwide as part of Illumina’s portfolio o...
Comanche drug for preeclampsia gets fast track designation
September 2023—Comanche Biopharma announced it has received fast track designation from the FDA for its CBP-4888 as a novel small interfering ribonucleic acid (siRNA) therapy for preeclampsia. ...
New book in Foundations in Diagnostic Pathology series
September 2023—Differential Diagnoses in Surgical Pathology: Tumors and their Mimickers, a new volume in the Foundations in Diagnostic Pathology series, has been published by Elsevier. The book...
Stago Max Generation systems get DOD authorization to operate
September 2023—Diagnostica Stago received an authorization to operate from the Department of Defense Health Agency (DHA) for the company’s Max Generation analyzers and middleware solution. Th...
FDA clears Siemens Atellica CI analyzer
September 2023—Siemens Healthineers announced that its Atellica CI analyzer for immunoassay and clinical chemistry testing has received FDA clearance and is available in many countries. The p...
GADx reintroduces IT-Leish test for visceral leishmaniasis
September 2023—Global Access Diagnostics announced the launch of IT-Leish, a UKCA-marked rapid test used for diagnosing visceral leishmaniasis. The company acquired the manufacturing rights for...
KSL Diagnostics opens transplant immunology laboratory
September 2023—KSL Diagnostics, Buffalo, NY, has opened a transplant immunology laboratory to serve the western New York region. KSL is the provider for Erie County Medical Center and Kaleida H...
Owen Mumford introduces Unistik venous blood collection devices
September 2023—Owen Mumford has introduced its Unistik venous blood collection devices. Unistik VacuFlip features a safety guard that flips over to cover the needle after it is withdrawn fr...
American Registry of Pathology Press digital library
September 2023—The American Registry of Pathology Press digital library offers a fully searchable books platform with full-text versions of the books in ARP Press’ current series of fascicles...
Evident Slideview DX VS-M1R digital scanner
September 2023—Evident has introduced its Slideview DX VS-M1R whole slide imaging system, for research use only. The post Evident Slideview DX VS-M1R digital scanner first appeared on CAP TO...
FDA clears Thermo Fisher assays for preeclampsia
September 2023—Thermo Fisher Scientific announced FDA clearance of its Brahms PlGF plus Kryptor and Brahms sFlt-1 Kryptor novel biomarkers for the risk assessment and clinical management of pre...
FDA clears respiratory viral panel for BD Max
September 2023—BD announced FDA 510(k) clearance for its BD Respiratory Viral Panel for the BD Max system. It is a single molecular diagnostic combination test that uses a single nasal or nasop...
Verichem reference materials for electrolyte testing
September 2023—Verichem Laboratories offers a line of liquid-stable, multianalyte kits for the calibration verification of electrolyte assays for use with systems employing flame photometer, di...
FDA clears Thermo Fisher chromogranin A assay
Sept. 28, 2023—Thermo Fisher Scientific announced FDA clearance of its Thermo Scientific Brahms CgA II Kryptor, an automated immunofluorescent assay for the quantitative determination of the co...
Pillar Biosciences launches OncoReveal Core LBx NGS kit
Sept. 27, 2023—Pillar Biosciences announced the global launch of OncoReveal Core LBx, a research use only, liquid biopsy–based next-generation sequencing kit for pan-cancer tumor profiling. ...
FDA clears Streck quality controls for bloodstream infections
Sept. 26, 2023—Streck announced that its MDx-Chex for BC-GP and MDx-Chex for BC-GN quality controls, designed to verify the performance of the Luminex Verigene Blood Culture Gram-Positive (BC-G...
BioMérieux submits 510(k), CLIA-waiver application for R/ST panel
Sept. 25, 2023—BioMérieux has submitted the BioFire SpotFire Respiratory/Sore Throat (R/ST) panel to the FDA for a dual 510(k) clearance and CLIA waiver. The post BioMérieux submits 510(k...
QuidelOrtho gets CLIA waiver for Sofia 2 SARS Antigen+ FIA
Sept. 22, 2023—QuidelOrtho has been granted a CLIA waiver from the FDA for its Sofia 2 SARS Antigen+ FIA. The post QuidelOrtho gets CLIA waiver for Sofia 2 SARS Antigen+ FIA first appeared o...
Evident announces alliance to automate digital pathology workflows
Sept. 19, 2023—Evident announced an alliance with Corista, Sakura Finetek, and Visiopharm to deliver an automated, end-to-end workflow solution for pathology in the United States. The post Ev...
Tests for paraneoplastic syndromes in neurology
September 2023—Laboratory testing for paraneoplastic neurologic syndromes is neither commonplace nor cheap. It also comes with its own enigmatical math, as Michael Levy, MD, PhD, recently exper...
Many knots to untangle in lab test names
September 2023—Ambiguities, inconsistencies, omissions, and other defects in the naming of laboratory tests can send test orders and results interpretation awry, particularly with some of the m...
For infectious disease, what tests and at what time in disease course
September 2023—For the tickborne and mosquito-borne arboviruses, which are frequently more transient in blood and tissue than other pathogens, both molecular and serologic testing have a place ...
Lab’s steps to fewer contaminated urine cultures
September 2023—A casual comment made in a routine exchange in an Avera McKennan Hospital laboratory sparked a five-year campaign to bring down the urine culture contamination rate. “I feel li...
New viscoelastic testing requirement in checklist
September 2023—A proficiency testing accreditation requirement in the new checklist edition was revised to add clarification, and a new requirement on viscoelastic testing will close an existin...
People, partners, and platforms at the point of care
September 2023—Point-of-care testing—the requests and the committees that oversee them, the connectivity, what AI might bring. CAP TODAY publisher Bob McGonnagle on July 21 met online with a ...
Disruptive technologies—what impact on lab workflow?
September 2023—New from CAP Publications is Disruptive Technologies in Clinical Medicine, by Frederick Kiechle, MD, PhD. In his new book Dr. Kiechle says “disruptive technologies offer new pa...
AMP case report: Lung micropapillary adenocarcinomas revisited
September 2023—CAP TODAY and the Association for Molecular Pathology have teamed up to bring molecular case reports to CAP TODAY readers. AMP members write the reports using clinical cases from...
Genetic counseling within the laboratory: For oncology cases, lab’s consult service plugs gap
September 2023—What happens when an oncologist cannot confidently determine what type of genetic test to order for their patient? Where can a provider turn if they do not know whether a genetic...
From the President’s Desk
September 2023—In the past two years, I’ve written a lot in this column about leadership and why pathologists make natural health care leaders. Effective leaders emerge from a process of cont...
Clinical pathology selected abstracts
September 2023—Approximately 30 percent of U.S. employees report that they have been bullied in the workplace, and these numbers are even higher for remote workers. Bullying is defined as any a...
Anatomic pathology selected abstracts
September 2023—Understanding of the pathologic and molecular features of endometrial cancer has advanced measurably since the FIGO (International Federation of Gynecology and Obstetrics) stagin...
Molecular pathology selected abstracts
September 2023—Neurodegenerative diseases are a broad group of disorders characterized by progressive loss of nerve cells in the central or peripheral nervous system. These diseases are often c...
Q&A column
SEPTEMBER 2023 Q. Some recent clinical guidelines recommend lower therapeutic and toxic limits for digoxin than those provided in assay package inserts. What therapeutic ranges and toxic threshol...
Newsbytes
September 2023—The musician Frank Zappa said, “One size does not fit all,” a declaration that counters the claims of many clothing manufacturers and holds true for a variety of products, in...
Put It on the Board
September 2023—A wrist-worn high-sensitivity cardiac troponin I monitor was one of the wearable devices and health monitors highlighted in a session on emerging technologies for point-of-care t...
Letters
September 2023—I read with interest “In anatomic pathology labs, a balancing act” (August 2023) . Some of the roundtable participants highlighted an area of next-generation-sequencing–bas...
https://www.captodayonline.com/letters-0923/?utm_source=rss&utm_medium=rss&utm_campaign=letters-0923
Pathology Visions 2023
“Igniting Digital Pathology Transformation”—the theme for Pathology Visions 2023 . The Digital Pathology Association (DPA) invites you to attend this year’s annual meeting taking place Oc...
CAP TODAY
“I am excited to see digital pathology fully launch and get implemented into mainstream practice. Digital pathology is for everyone because it encompasses so many things and can be successfully...
Primera unveils Signature EVO slide and cassette printers
Sept. 12, 2023—Primera Technology has launched its next-generation Signature EVO slide printer and Signature EVO cassette printer. The post Primera unveils Signature EVO slide and cassette pr...
HER2 Testing in Metastatic Colorectal Cancer (mCRC)
Webinar presenters Jaclyn Hechtman, MD, and John Marshall, MD, discuss how HER2 testing in mCRC opens a powerful new window for patients, testing methodology to identify HER2+ mCRC, a new treatm...
Tribun Health secures €15 Million in series B funding
Sept. 6, 2023—Paris-based Tribun Health announced the completion of its series B funding, securing an investment of €15 million. The post Tribun Health secures €15 Million in series B fun...
Experience high resolution cassette printing
Enhance traceability in your laboratory with crisp, clear print on the surface of the cassette. Learn more . The post Experience high resolution cassette printing first appeared on CAP TODAY ...
MMQCI releases BCR-ABL linearity panel
Aug. 28, 2023—Maine Molecular Quality Controls released the Xpert BCR-ABL IS p210 Linearity Panel C207, intended for use as an assayed external quality control to monitor the performance of the...
Evident introduces Slideview DX VS-M1R digital scanner
Aug. 25, 2023—Evident has introduced its Slideview DX VS-M1R whole slide imaging system, for research use only. The post Evident introduces Slideview DX VS-M1R digital scanner first appeared...
FDA clears PixCell HemoScreen for direct capillary sampling
Aug. 24, 2023—PixCell Medical announced that the FDA has granted 510(k) clearance for direct capillary sampling with the HemoScreen 5-part differential CBC analyzer. The post FDA clears PixCe...
Sophia Genetics expands relationship with Gustave Roussy
Aug. 23, 2023—Sophia Genetics announced the expansion of its relationship with Gustave Roussy in which the cancer center will use the Sophia DDM digital analytics platform for all relevant samp...
Rhodes Group releases white paper on risk adjustment strategy
Rhodes Group, a wholly owned subsidiary of TriCore, has published a white paper on the value of using laboratory results within a risk adjustment identification strategy. By using TriCore’s la...
Cole-Parmer ultra-low temp freezers
August 2023—Cole-Parmer introduced its North Sciences/Traceable TSi and TEC2 series ultra-low temperature freezers. The self-monitoring freezers are integrated with a Traceable data logger that...
Verichem calibration verification reference materials
August 2023—A multilevel set of liquid-stable clinical reference materials for use with ammonia and iron testing are available from Verichem Laboratories. The five-level standard kit, along wit...
Werfen completes acquisition of Immucor
August 2023—Werfen announced it has completed the acquisition of Immucor after obtaining all necessary regulatory and antitrust approvals. The purchase price was about $2 billion. The post We...
FBI approves Qiagen ForenSeq Mainstay workflow for NDIS
August 2023—Qiagen announced that the U.S. Federal Bureau of Investigation has approved its ForenSeq Mainstay workflow, allowing accredited forensic DNA laboratories to process DNA casework sam...
OncoHost, BGN Technologies sign option agreement
August 2023—OncoHost has signed an option agreement with BGN Technologies, the technology transfer company of Ben-Gurion University of the Negev (Be’er Sheva, Israel), to receive a license fo...
Siemens ELF test gets FDA breakthrough device designation
August 2023—The FDA has granted a breakthrough device designation for Siemens Healthineers Enhanced Liver Fibrosis test, the only blood test granted FDA marketing authorization for prognosticat...
FDA approves ARUP Labs AAV5 DetectCDx
August 2023—ARUP Laboratories announced that the FDA approved AAV5 DetectCDx as a companion diagnostic to aid in the selection of adult patients eligible for treatment with Roctavian (valoctoco...
Illumina launches DRAGEN 4.2
August 2023—Illumina launched the latest version of its DRAGEN software, version 4.2, for analyzing next-generation sequencing data. New features of the software include increased single nucleo...
Bio-Rad launches second installment in QC workbook series
August 2023—Bio-Rad Laboratories has published the second workbook in a series that offers Professional Acknowledgement for Continuing Education credits. The second installment, titled “Labor...
LGC launches Seraseq 22q11 female-matched reference material
August 2023—LGC Clinical Diagnostics announced that its Trisomy 22q11 Female-Matched Reference Material is now included in its Seraseq noninvasive prenatal testing portfolio. It is a circulatin...
Pathology Visions 2023
Aug. 17, 2023—The Digital Pathology Association annual meeting, Pathology Visions 2023, will take place Oct. 29–31 in Orlando, Fla. The post Pathology Visions 2023 first appeared on CAP TO...
Low level limbo in HER2 breast cancer
August 2023—Seemingly channeling the inspiration of Magritte and his famous pipe, pathologists are painting a new picture of what has long been an everyday object in their own world: HER2. To p...
For patients, demystifying pathology reports
August 2023—With patient access to pathology reports now common via online portals, the question some have asked is what can be done to make them easier for patients to understand. The p...
Few but notable— new accreditation checklist changes
August 2023—Climate control, calculation verification, block retention, and histocompatibility section director (technical supervisor) qualifications are among the areas in which laboratories c...
Upon viral infection, assessing the host nasal epigenome
August 2023—Analyzing the nasal epigenome can shed light on viral infections, strain differences, and potentially infection severity, and for influenza B in particular the results are striking....
In anatomic pathology labs, a balancing act
August 2023—Anatomic pathology laboratories—the pressures, the promise of technology to alleviate them, and the seemingly unprecedented rates of change. CAP TODAY publisher Bob McGonnagle gat...
New cassette printer a standout? Users think so
August 2023—No jams, downtime, or lost time. Plenty of savings, speed, and employee satisfaction. Users of what General Data calls its next-generation cassette printer for histology laboratorie...
AMP case report: Small intragenic structural variants in SATB2-associated syndrome
CAP TODAY and the Association for Molecular Pathology have teamed up to bring molecular case reports to CAP TODAY readers. AMP members write the reports using clinical cases from their own practi...
Cytopathology in focus: How to approach cytology of unknown primary
August 2023—We discuss in this article a common problem that all cytopathologists come across frequently in their practice: tumors of unknown primary origin involving body fluids and other site...
Cytopathology in focus: Impact of primary HPV testing on cytology lab statistical analysis
August 2023—Cytology gynecologic statistical laboratory data must be analyzed in the context of changing screening modalities and patient populations. This is especially important with the incr...
Cytopathology in Focus: Lung cytopathology reporting: WHO system and cases
August 2023—Accurate and timely diagnosis is the cornerstone of effective patient care, particularly in the field of pulmonary pathology. To address the challenges health care professionals fac...
In memoriam
August 2023—Peachy Ridgway Gilmer Jr., MD, a member of the CAP Board of Governors from 1985 to 1991, died on June 18 at age 90. Dr. Gilmer was vice chair of the CAP Council on Education and Mem...
FDA clears Abbott Alinity h-series hematology system
Aug. 16, 2023—Abbott has received FDA clearance for its Alinity h-series hematology system, which includes the Alinity hq, an automated hematology analyzer, and Alinity hs, an integrated slide ...
From the President’s Desk
August 2023—The benefit of the doubt: a risk worth taking in health care? Many of us work in practices, hospitals, or departments that are short-staffed. In the aftermath of the pandemic, it is...
Clinical pathology selected abstracts
August 2023—Burnout has been reported to affect as many as 44 percent of physicians. It is listed in the International Classification of Diseases 11th Revision (ICD-11) and has been attributed ...
Anatomic pathology selected abstracts
August 2023—Gastric foveolar-type adenoma is a rare benign neoplasm that occurs sporadically or presents in patients with familial adenomatous polyposis. The molecular features of foveolar-type...
Molecular pathology selected abstracts
Augstus 2023—Atypical hemolytic uremic syndrome is a rare, potentially life-threatening thrombotic microangiopathy. The disorder causes tiny blood clots to form in blood vessels and results in ...
Q&A column
AUGUST 2023 Q. Is there a CAP guideline that recommends that patients stop taking drugs that may interfere with a blood or urine test before providing a specimen? Read answer . Q. Can laboratory ...
Newsbytes
August 2023—How often do pathology departments underbill insurance companies for their services? And how much money do they lose because of underbilling mistakes? A prototype dashboard at Dartm...
Put It on the Board
August 2023—The Association for Diagnostics and Laboratory Medicine (formerly AACC) and the American Diabetes Association last month issued guidelines and recommendations for laboratory analysi...
FDA approves Qiagen CDx for gastrointestinal stromal tumors
Aug. 9, 2023—Qiagen announced FDA approval of its Therascreen PDGFRA RGQ PCR kit, a companion diagnostic intended for use to aid clinicians in identifying patients with gastrointestinal stromal...
Mainz advanced adenoma biomarkers feasibility study results
Aug. 7, 2023—Mainz Biomed announced results of an independent feasibility study conducted in collaboration with members of the National Cancer Institute’s Early Detection Research Network to ...
HemoSonics Quantra awarded Innovative Technology contract
Aug. 4, 2023—HemoSonics announced that its Quantra hemostasis system has received an Innovative Technology contract award from Vizient, whose members include more than half of all acute care ho...
Hc1 partners with AON to develop Workforce Optimization
Aug. 2, 2023—Hc1 announced a development partnership with American Oncology Network. The post Hc1 partners with AON to develop Workforce Optimization first appeared on CAP TODAY .
FDA clears respiratory viral panel for BD Max
Aug. 1, 2023—BD announced FDA 510(k) clearance of its BD Respiratory Viral Panel for the BD Max system. The post FDA clears respiratory viral panel for BD Max first appeared on CAP TODAY .
HM525 NX Cryostat Product Overview from Epredia
This video provides a product demonstration detailing the key features and benefits of the Cryostar HM525 NX Cryostat from Epredia. Cryostats from Epredia are designed to enable laboratories to q...
CAP TODAY
SEE THE LASERTRACK FLEX CASSETTE PRINTER FOR HISTOLOGY The LaserTrack™ FLEX™ Cassette Printer is a revolutionary new concept for cassette printing in histology labs. Instead of being locke...
Werfen completes acquisition of Immucor
July 27, 2023—Werfen announced it has completed its acquisition of Immucor after obtaining all necessary regulatory and antitrust approvals. The post Werfen completes acquisition of Immucor ...
Recommendations for reporting race free estimated glomerular filtration rate
Webinar presenter GREG MILLER, PHD, Professor of Pathology, Director of Pathology Information Systems, Co-Director of Clinical Chemistry, Virginia Commonwealth University Health System, Richmond...
Illumina, Pillar Biosciences announce partnership
July 25, 2023—Illumina and Pillar Biosciences announced a strategic partnership to make Pillar’s suite of oncology assays commercially available worldwide as part of Illumina’s portfolio of...
HNL selects Proscia, Leica for digital pathology
July 24, 2023—HNL Lab Medicine announced it has selected solutions from Proscia and Leica Biosystems to establish an advanced digital pathology practice. The post HNL selects Proscia, Leica f...
FDA clears Siemens Atellica CI analyzer
July 20, 2023—Siemens Healthineers announced that its Atellica CI analyzer for immunoassay and clinical chemistry testing has received FDA clearance and is now available in many countries. Th...
LGC launches Accurun MS2 internal control
July 2023—LGC Clinical Diagnostics has launched the SeraCare Accurun MS2, a full-process internal control that can be used as a tool to monitor the process integrity of sample extraction and am...
General Data LaserTrack Flex cassette printer
July 2023—General Data Healthcare’s Flex is the latest addition to its LaserTrack portfolio of cassette printers. The post General Data LaserTrack Flex cassette printer first appeared on C...
Randox acquires Cellix
July 2023—Randox (Crumlin, U.K.) has acquired Cellix, a Dublin-based company that develops microfluidic tools and impedance flow cytometers for cell analysis. The post Randox acquires Cellix ...
Verichem offers free data reduction reports
July 2023—Verichem Laboratories now offers its customers free access to its Web-based and online calibration verification data reduction and test-reporting programs. Designed for use with the c...
OGT partners with Applied Spectral Imaging
July 2023—OGT, a Sysmex Group company, announced a commercial partnership with Applied Spectral Imaging. The agreement will grant OGT rights to market ASI’s proprietary cytogenetic imaging an...
Siemens to distribute Scopio digital cell morphology platforms
July 2023—Siemens Healthineers has entered into an agreement with Scopio Labs to distribute the Scopio X100 and Scopio X100HT. These imaging platforms will complement Siemens hematology systems...
BD launches FacsDuet Premium system
July 2023—BD announced the worldwide commercial launch of its BD FacsDuet Premium system. The automated instrument prepares samples for in vitro diagnostic and user-defined tests, including coc...
Bio-Rad launches bulk urine, CSF negative controls
July 2023—Bio-Rad Laboratories launched two Exact Diagnostics products, Bulk Urine Negative and Bulk CSF Negative controls. The bulk urine negative control is intended to be validated as an ind...
Danish National Genome Center selects Qiagen’s QCI Interpret
July 2023—Qiagen announced that its variant interpretation and reporting software, Qiagen Clinical Insight (QCI) Interpret, was chosen by the Danish National Genome Center to provide interpreta...
FDA clears Immuno Concepts IgG Anti-nDNA test system
July 2023—Immuno Concepts announced FDA 510(k) clearance of its IgG Anti-nDNA fluorescent test system for use with the company’s Image Navigator system. The test is for in vitro diagnostic us...
Bruker launches TimsTOF Ultra mass spectrometer
July 2023—Bruker Corp. launched its TimsTOF Ultra mass spectrometer at the American Society for Mass Spectrometry annual conference, June 4–8, in Houston, Tex. TimsTOF Ultra can identify, wit...
Safety-Spec launches gross room trays
July 2023—Safety-Spec launched its Safety-Spec Gross Room Tray. The reusable trays are designed to ensure tissue specimens are easily accessible, properly labeled, and neatly organized. Each tr...
RMT introduces RmtHealthCheck
July 2023—Remote Medical Technologies introduced RmtHealthCheck, a new feature of the company’s RmtConnectPlus real-time telepathology solution. It notifies users via email of network disrupt...
Leica launches Bond ChromoPlex II Dual Detection kit
July 2023—Leica Biosystems launched its Bond ChromoPlex II Dual Detection kit for use in immunohistochemistry and chromogenic in situ hybridization on Bond-Max and Bond-III instruments. The p...
Turning questions to answers in drug testing
July 2023—As she surveys the opioid epidemic in North America, Christine Snozek, PhD, D(ABCC), could be tempted to think that a ripped-from-the-headlines reality has landed in clinical laborato...
For SARS-CoV-2, clearing the air on EUA tests
July 2023—As the COVID-19 federal public health emergency drew to a close in mid-May, industry experts explained what will and won’t change for the laboratory and weighed the fallout from the...
The human gut microbiome and blood biochemistry connection
July 2023—The human microbiome has been called the forgotten organ, and at one time it was. But not in the past 10 years. James Versalovic, MD, PhD, made that clear in his talk at the Associati...
Siemens ELF test gets FDA breakthrough device designation
July 18, 2023—The FDA has granted a breakthrough device designation for Siemens Healthineers Enhanced Liver Fibrosis Test, the only blood test granted FDA marketing authorization for prognostic...
For sepsis Dx, MDW biomarker brought into the mix
July 2023—When Butler Health System in early 2020 installed the Beckman Coulter DxA 5000 automation line, its hospitals were among the first in the country to do so. At the same time, Butler we...
Cytomegalovirus in IBD: where to biopsy, whom to treat
July 2023—Though it’s been suggested that newer drugs have made cytomegalovirus less relevant in patients with inflammatory bowel disease, CMV remains an important opportunistic infection in ...
First a probe purchase, then an academic consortium
July 2023—Bringing new technology into laboratories is important for pathology as a field and for patients—and only getting more difficult. “Each new wave of technology is more complicated ...
Lab leaders on moving markets and tipping points
July 2023—Digital pathology, the pathology workforce, and the clinical demand for subspecialty expertise were some of what Compass Group lab leaders took on in their June 6 conversation, with C...
AMP case report: A germline GATA2 c.121C>G (p.P41A) variant in a patient with an unusual acute promyelocytic leukemia
July 2023—A germline GATA2 c.121C>G (p.P41A) variant in a patient with an unusual acute promyelocytic leukemia CAP TODAY and the Association for Molecular Pathology have teamed up to bring mole...
From the President’s Desk
July 2023—About a year ago, I used this column to talk about the CAP’s efforts to prioritize innovation and to create more pathways for staff and members to help keep us on the cutting edge. ...
Clinical pathology selected abstracts
July 2023—Hemolytic disease of the fetus and newborn is caused by maternal immunoglobulin G crossing the placenta and binding to fetal RBC antigens. In severe cases, it results in fetal or neon...
Anatomic pathology selected abstracts
July 2023—High-grade appendiceal mucinous neoplasm is a relatively recent term that describes a rare epithelial neoplasm of the appendix that demonstrates pushing-type invasion but high-grade c...
Molecular pathology selected abstracts
July 2023—Non-muscle-invasive bladder cancer accounts for the majority of bladder tumors and is typically treated with transurethral resection of the bladder tumor followed by adjuvant intraves...
Q&A column
JULY 2023 Q. Should phosphate analysis be added to the comprehensive metabolic panel, especially given the test’s usefulness in distinguishing various bone disorders?Read answer . Q. Is it impo...
Newsbytes
July 2023—The Permanente Medical Group, Oakland, Calif., has launched the Kaiser Permanente Northern California Division of Research Augmented Intelligence in Medicine and Healthcare Initiative...
Put It on the Board
July 2023—Roche’s Elecsys beta-Amyloid (1-42) CSF II (Abeta42) and Elecsys Total-Tau CSF assays (tTau) have received Food and Drug Administration 510(k) clearance. They are used as a tTau/Abe...
FDA clears Roche tTau/Abeta42 Alzheimer’s assays
June 28, 2023—Roche announced that its Elecsys beta-Amyloid (1-42) CSF II (Abeta42) and Elecsys Total-Tau CSF (tTau) assays have received FDA 510(k) clearance and will be available in Q4 2023. ...
Danish National Genome Center selects Qiagen’s QCI Interpret
June 26, 2023—Qiagen announced that its variant interpretation and reporting software, Qiagen Clinical Insight (QCI) Interpret, was chosen by the Danish National Genome Center to provide interp...
Randox acquires Cellix
June 23, 2023—Randox (Crumlin, U.K.) has acquired Cellix, a Dublin-based company that develops microfluidic tools and impedance flow cytometers for cell analysis. The post Randox acquires Cel...
Dark Daily to present free webinar on Z-Code application process
UnitedHealthcare is requiring, effective Aug. 1, that genetic test claims associated with about 250 CPT codes include a Z-Code issued by the MolDx Diagnostic Exchange (DEX) registry, operated by ...
Worthington Biochemical product catalog
June 2023—Worthington Biochemical announced that the 23rd edition of its enzyme and biochemical catalog is now available in print and digital formats. The catalog covers a wide array of product...
BioMérieux launches BioFire Fireworks software
June 2023—BioMérieux has launched BioFire Fireworks, an integrated software solution for BioFire systems that is part of the company’s Vision Suite data-management product line. Fireworks pr...
Early Lyme disease detection
June 2023—Zeus Scientific has introduced the Zeus Borrelia Modified Two-Tiered Testing (MTTT) algorithm, an FDA-cleared all-ELISA algorithm designed to improve the detection of early Lyme disea...
Momentum Consulting offers plan for lab optimization
June 2023—Momentum Consulting has kicked off its laboratory optimization program for CLIA labs that are emerging from the COVID pandemic with broad or specific needs. The plan covers maximizing...
Visiopharm launches Ki-67 algorithm
June 2023—Visiopharm announced the launch of a next-generation Ki-67 algorithm designed to automate the scoring of Ki-67 slides. Tumor nuclei are counted based on their Ki-67 expression and the...
SeraCare releases solid tumor CNV reference material
June 2023—LGC SeraCare has developed a comprehensive solid tumor copy number variation reference material in a formalin-fixed, paraffin-embedded format. The Seraseq FFPE Solid Tumor CNV RM incl...
ZeptoMetrix introduces Protrol QC material
June 2023—ZeptoMetrix introduced Protrol, a line of products designed to evaluate and monitor the performance of antigen-based assays, including lateral flow immunoassays for infectious disease...
FDA clears immunoassays to assess risk of preeclampsia
June 2023—Thermo Fisher Scientific announced the FDA has cleared the Thermo Scientific Brahms PlGF Plus Kryptor and Brahms sFlt-1 Kryptor novel biomarkers, both of which received breakthrough d...
Siemens launches Atellica Hema analyzers
June 2023—Siemens Healthineers launched two solutions for high-volume hematology testing, the Atellica Hema 570 analyzer and Atellica Hema 580 analyzer. Both have a throughput rate of up to 120...
Labcorp gets exclusive license for Proteomedix prostate cancer test
June 2023—Proteomedix (Schlieren, Switzerland) announced an exclusive license agreement in which Labcorp will develop and commercialize its Proclarix prostate specific antigen test in the Unite...
Quansys Biosciences bovine-specific ELISAs
June 2023—Quansys Biosciences has developed Q-Plex Bovine Cytokine Panel 1 (5-plex), an ELISA kit that can measure five levels of bovine and African water buffalo cytokines in plasma, serum, an...
FDA clears Panther Fusion SARS-CoV-2, flu, RSV assay
June 2023—Hologic announced the FDA has granted 510(k) clearance for its Panther Fusion SARS-CoV-2/Flu A/B/RSV assay. This molecular diagnostic test, previously under EUA, detects and different...
Trane Technologies acquires Helmer Scientific
June 2023—Trane Technologies has acquired Helmer Scientific. Trane says the acquisition will broaden its capabilities in precision temperature control and its existing portfolio of life science...
Verichem calibration verifiers for cholinesterase testing
June 2023—Verichem Laboratories offers multilevel calibration verification materials for cholinesterase activity as part of its liquid-stable and ready-to-use Enzyme ER Verifier kit. The verifi...
BD gets clearance for MRSA diagnostics AI software
June 2023—BD received FDA 510(k) clearance for the BD Kiestra methicillin-resistant Staphylococcus aureus imaging application, which uses artificial intelligence to automate the task of inspect...
Beckman Coulter unveils DxI 9000 Access
June 2023—Beckman Coulter unveiled its DxI 9000 Access immunoassay analyzer. The analyzer can run up to 215 tests per hour per square meter and does not require daily maintenance; its weekly ma...
Randox introduces PSA and BNP control
June 2023—Randox Labs has released two new products, a prostate-specific antigen and brain natriuretic peptide control. The liquid-frozen PSA is manufactured using human serum and has an open-v...
FDA clears Stago Max Generation 3 analyzers
June 21, 2023—Diagnostica Stago announced FDA 510(k) clearance of its Max Generation 3 analyzers, the STA R Max 3 and STA Compact Max 3. The analyzers feature a mechanical viscosity-based detec...
Study shows clinical value of QFT-Plus with CD8 technology
June 19, 2023—Qiagen announced the publication of a study that aimed to compare and analyze the difference in interferon-gamma (IFN-γ) production between QuantiFeron-TB Gold Plus TB1 and TB2 b...
In search for Candida auris, labs all in
June 2023—A bad-news, good-news, bad-news, good-news bass line thrums through the ongoing story of Candida auris as it continues to spread in the United States. Initially identified in Japan, i...
Lyme algorithms: stick to standard, move to modified?
June 2023—For Lyme disease testing, immunoblots became optional in 2019 when the FDA cleared enzyme immunoassays for use as part of a modified two-tiered testing algorithm. “It was a histor...
Reorganize, promote, shift, assess—staying staffed amid a shortage
June 2023—The labor shortage may ease now and then for some laboratories in some areas, but the general outlook is that it will stick around for a while—if not forever. The post Reorganize,...
Weighing the risks in HIV, HCV algorithmic testing
June 2023—For HIV and HCV algorithmic testing, the workflow options have risks to consider. Molecular testing performed as an automatic reflex on the same sample used for the serologic testing ...
Workflow, specimen transport under the lens at AACC
June 2023—Transporting specimens to the laboratory, and processing and distributing them within the lab, will be what AACC meeting-goers hear about in a session next month. The post Workflow,...
Kaiser, Geisinger: the first of similar headlines?
June 2023—Consolidation in health care makes the news often. But the coming together of Kaiser Permanente and Geisinger Health and their launch of Risant Health got special attention. CAP TODAY...
ABPath’s plans for transparency, competency pilot
June 2023—Three initiatives are underway at the American Board of Pathology, one of which its CEO Gary Procop, MD, MS, describes as “a new era of transparency and collaboration.” The post...
Appendiceal lesions: features, subtypes, patterns
June 2023—Although goblet cell adenocarcinoma can label for neuroendocrine markers, it behaves as an adenocarcinoma and is staged as such. And it’s important to distinguish goblet cell adenoc...
The intersection of news, core labs, and lab costs
June 2023—As CAP TODAY assembled its annual guides to chemistry and immunoassay analyzers (for this issue and the July issue), publisher Bob McGonnagle brought together IVD manufacturers and la...
From the President’s Desk
June 2023—I embarked this year on my first international travel as president of the CAP. Due to limitations from the pandemic, I haven’t been able to do as much of this as some of my predeces...
Clinical pathology selected abstracts
June 2023—Studies that address whether the incidence of dementia in the U.S. population is declining are inconsistent. They cannot establish conclusive trends in disease rates. Most studies are...
Anatomic pathology selected abstracts
June 2023—The authors conducted a study to examine whether quantitative digital pathology can derive valuable information from readily available and inexpensive H&E slides and thereby augment r...
Molecular pathology selected abstracts
June 2023—Endometriosis is defined by the presence of endometrial-like tissue outside of the uterus and can cause debilitating pelvic pain and often infertility. It has also been associated wit...
Q&A column
JUNE 2023 Q. California Senate Bill 864 requires that fentanyl screening be included in every drug screen performed in a general acute-care hospital laboratory. The problem is there are no FDA-ap...
Newsbytes
June 2023—The time it takes to read through numerous pathology reports to find nuggets of critical information buried within narrative sections of text is tantamount to the time it takes for ca...
Put It on the Board
June 2023—The Association for Molecular Pathology and the National Society of Genetic Counselors released in May a report containing eight recommendations for next-generation sequencing germlin...
Rapid Lung NGS is enabling clinicians and reducing biomarker testing costs
Webinar presenters Lauren Ritterhouse, MD, PhD, and Ibiayi Dagogo-Jack, MD, discuss consolidating NSCLC biomarker testing into a rapid lung NGS program, what the positive implications are for on...
Horiba_eNEWS_061223
300×250 The post Horiba_eNEWS_061223 first appeared on CAP TODAY .
Leica launches Bond ChromoPlex II Dual Detection kit
June 9, 2023—Leica Biosystems launched its Bond ChromoPlex II Dual Detection kit for use in immunohistochemistry and chromogenic in situ hybridization on Bond-Max and Bond-III instruments. Th...
FDA clears Panther Fusion SARS-CoV-2/Flu A/B/RSV assay
May 24, 2023—Hologic announced the FDA has granted 510(k) clearance for its Panther Fusion SARS-CoV-2/Flu A/B/RSV assay. The post FDA clears Panther Fusion SARS-CoV-2/Flu A/B/RSV assay ...
Sarstedt launches NFT urine collection system
May 2023—Sarstedt’s new Needle-Free Transfer Urine Collection System is a closed urine collection system for needle-free transfer of urine from the needle-free cup or urine collection contain...
Verichem calibration verifiers, reference materials
May 2023—Verichem Laboratories now offers multilevel calibration verification materials for amylase and lipase activity as part of its liquid-stable, ready-to-use Enzyme ER Verifier kit. The pr...
Quest to acquire Haystack Oncology
May 2023—Quest Diagnostics and Haystack Oncology, an early-stage oncology company focused on minimal residual disease testing, announced on April 27 a definitive agreement for Quest to acquire ...
FDA expands approval for Ventana PD-L1 assay
May 2023—Roche announced FDA approval of the Ventana PD-L1 (SP263) assay as a companion diagnostic to identify patients with locally advanced and metastatic non-small cell lung cancer eligible ...
Tempus gets FDA approval for xT CDx
May 2023—Tempus announced that the FDA has approved the company’s premarket approval application for its companion diagnostic test, xT CDx, to identify patients who may benefit from treatment...
Sysmex Inostics, Genomic Testing Cooperative partnership
May 2023—Sysmex Inostics and Genomic Testing Cooperative formed a strategic partnership for Sysmex Inostics to commercialize GTC’s tissue and liquid biopsy solid tumors and hematology assay s...
QuidelOrtho gets de novo authorization for Sofia 2 SARS Antigen+ FIA
May 2023—QuidelOrtho Corp. has been granted a de novo request from the FDA for its new Sofia 2 SARS Antigen+ FIA, a lateral flow immunofluorescent assay that is used with the Sofia 2 fluorescen...
Illumina launches Connected Insights software
May 2023—Illumina announced the release of Connected Insights, a cloud-based software for tertiary analysis of clinical next-generation sequencing data. The software enables labs to connect to ...
Maine Molecular releases SpotFire RSP controls
May 2023—Maine Molecular Quality Controls has released SpotFire RSP positive and RSP negative controls. The quality controls are for use in monitoring the performance of in vitro laboratory nuc...
Tissue‑Tek block filing cabinet
May 2023—Sakura Finetek has launched its Tissue‑Tek Block Filing Cabinet 2400, which has six drawers and a capacity of 2,400 paraffin-embedded tissue blocks. The post Tissue‑Tek block fil...
Bio-Rad launches Cardiac Advance quality controls
May 2023—Bio-Rad Laboratories has launched Cardiac Advance, a four-level multianalyte cardiac quality control for high-sensitivity troponin testing. The post Bio-Rad launches Cardiac Advance ...
TriCore goes live with X-Lab’s Labgnostic
May 22, 2023—X-Lab announced that TriCore Reference Laboratories will go live with its product Labgnostic to transition TriCore's paper-based orders and results workflows to fully electronic wo...
Siemens launches Atellica Hema analyzers
May 18, 2023—Siemens Healthineers launched two solutions for high-volume hematology testing, the Atellica Hema 570 analyzer and Atellica Hema 580 analyzer. The post Siemens launches Atellica ...
Preclinical medical students and pathologists: departing from the text
Despite diminishing classroom contact with medical students in the preclinical years, pathologists continue to be asked to teach year one and two students about the diseases delineated in textboo...
Colorectal cancer next on HER2 horizon
May 2023—Behold the common coin. Note its two sides, its easy flippability. Here is Joseph Pizzolato, MD, with the first coin toss. Given the expanded use of biomarkers with a variety of tumors...
Zeus Scientific MTTT algorithm for Lyme disease detection
May 17, 2023—Zeus Scientific has introduced the Zeus Borrelia Modified Two-Tiered Testing (MTTT) algorithm, an FDA-cleared all-ELISA algorithm designed to improve the detection of early Lyme d...
Alzheimer’s biomarkers: CSF reports, plasma prospects
May 2023—For fluid biomarkers in the diagnosis of Alzheimer’s disease, the pace of research and related industry and regulatory developments in the past year has been brisk. The post Alzhei...
‘Hundreds of variants’—Staying alert to HbA1c method interference
May 2023—Of the five methods used to measure HbA1c—immunoassay, boronate affinity, enzymatic, capillary electrophoresis, and ion-exchange HPLC—only the latter two can alert the laboratory a...
In-house or send-out? Lab approaches to gene panels
May 2023—Achieving standardization and setting up processes around the use of next-generation sequencing panels for the care of patients with cancer is a long road requiring a lot of expertise....
Supported? Satisfied? Keeping staff from moving on
May 2023—When hiring is difficult, how to improve retention becomes what it’s all about. Linking sign-on bonuses with performance metrics rather than time in the job is one way to try to reta...
Appendiceal lesion cases, clues, and cautions
May 2023—How to distinguish appendiceal diverticular disease and appendiceal polyps from mucinous neoplasms was just part of a CAP22 course on appendiceal lesions, led by Maryam Pezhouh, MD, MS...
The outlook for in-house next-generation sequencing
May 2023—Bringing next-generation sequencing in-house was at the center of a March 27 roundtable led by CAP TODAY publisher Bob McGonnagle, with costs, reimbursement, equity, and the electronic...
Inside the WHO Reporting System for Pancreaticobiliary Cytopathology
May 2023—Standardized reporting systems have been developed during the past decade for cytopathology of different organ systems including the pancreaticobiliary system. The Papanicolaou Society...
Adequacy in cytopathology: focus on cytology specimen use in molecular testing
May 2023—In the first article in our series on adequacy in cytology, published in January 2023 (bit.ly/3MDNVzr ), we summarized current approaches to defining adequacy for the purpose of primar...
Trane Technologies acquires Helmer Scientific
May 16, 2023—Trane Technologies has acquired Helmer Scientific. The post Trane Technologies acquires Helmer Scientific first appeared on CAP TODAY .
From the President’s Desk
May 2023—The spring of 2003 was not an easy time for me. I was taking care of my kids, a four-year-old and an infant, while going through a divorce. I had just started a new job and felt all th...
Clinical pathology selected abstracts
May 2023—Several studies have evaluated the brain protective role of the Mediterranean-DASH (Dietary Approaches to Stop Hypertension) Intervention for Neurodegenerative Delay (MIND) diet. The s...
Anatomic pathology selected abstracts
May 2023—Although criteria for malignancy have been established for glomus tumors of soft tissue, no accepted criteria exist for gastroesophageal glomus tumors, which are considered to behave u...