May 2024—If anything keeps Arturo Casadevall, MD, PhD, lying awake at night, it’s the frogs. And the bats. Also, the patients (relatively few, at least for now) who are affected by invasive f...
May 2024—In a time of wellness testing and high rates of levothyroxine prescribing for hypothyroidism, it may also be time to rethink TSH test result interpretation. The post Digging into the...
May 2024—Many laboratories have brought order to chaos in test ordering by launching initiatives to do so, for cost and staff savings and patient care benefits. TriCore is one—it set its sigh...
May 2024—What is a lupus anticoagulant (LA)? LA is somewhat of a misnomer. Many patients with this condition do not have systemic lupus erythematosus (SLE) and usually do not bleed. However, th...
Four views of artificial intelligence in pathology and laboratory medicine. That’s what panelists provided for attendees at the 7th Clinical Lab 2.0 workshop in late February in Chicago. The Un...
May 2024—The number of “champions” who have joined the CAP’s Future Pathologist Champion program grew from 71 in 2022 to 135 in 2023 and now stands at 222, and the goal is to reach 250 by...
May 2024—Laboratory-developed testing as it relates to next-generation sequencing was up first in the NGS conversation led online by CAP TODAY publisher Bob McGonnagle on March 19. Other topics...
May 2024—Classically, immunohistochemical expression of small cell lung cancer (SCLC) is characterized by strong expression of neuroendocrine markers, notably synaptophysin, chromogranin A, ins...
May 2024—Breast cancer continues to remain a major global health issue and one of the main leading causes of cancer mortality among women worldwide. The majority of breast cancer mortality is a...
May 2024—Fine-needle aspiration has been an important diagnostic tool for the workup of patients with abnormal enlargement of lymph nodes and related organs, including the spleen and thymus. ...
May 2024—You may have read my column in the March issue about how the CAP is taking care of the next generation of pathologists by helping and engaging our new-in-practice colleagues. If you’...
May 2024—Massive hemorrhage is a major cause of death in children, and the mortality rate from life-threatening hemorrhage is estimated to be 20 to 51 percent. To counter this high mortality ra...
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 .
May 2024—The Bethesda System for Reporting Thyroid Cytopathology described four subclasses of atypia within the atypia of undetermined significance category: nuclear (AUS-Nuc), architectural (A...
May 2024—Immunotherapy has revolutionized cancer treatment by recruiting the patient’s immune system to detect and destroy cancer cells. Immunotherapy often involves immune checkpoint blockad...
MAY 2024 Q. I know that CLIA is changing and more tests/analytes will become CMS regulated, along with other changes. Can you provide some background and an overview of the changes and when they ...
May 2024—The FDA has granted marketing authorization, through the de novo pathway, for Prenosis’ Sepsis ImmunoScore artificial intelligence-enabled software as a medical device, or SaMD, for ...
May 2024—Risant Health has completed its acquisition of Geisinger as its first health system dedicated to increasing access to value-based care and coverage. Risant says the organizations toget...
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 ...
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...
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...
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...
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...
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...
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...
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...
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 ...
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...
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...
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...
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...
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...
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...
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...
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 ...
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...
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 ...
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...
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...
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...
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...
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 ...
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...
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. ...
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...
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, 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...
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...
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...
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...
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...
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...
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 ...
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 ...
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...
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...
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 ...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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 ...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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 ...
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
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 ...
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. ...
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...
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...
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...
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. ...
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...
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...
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. ...
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...
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...
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...
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)...
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...
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...
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...
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...
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 ...
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 ...
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...
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...
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 ...
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...
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...
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...
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 ...
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 ...
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 ...
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...
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...
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...
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...
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...
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...
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,�...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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 ...
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...
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...
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...
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...
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...
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 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...
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...
Webinar presenter JADE NEFF, MD, PHD, Assistant Professor of Pathology, Duke University Medical Center, discusses Definitive Diagnosis of Idiopathic Multicentric Castleman Disease (iMCD), includi...
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...
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...
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...
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....
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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? ...
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...
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...
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...
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...
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...
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. ...
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, ...
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...
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...
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...
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, ...
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...
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...
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...
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...
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 ...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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 ...
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...
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 ...
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...
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...
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...
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 ...
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...
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...
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...
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...
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...
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...
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...
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...
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 ...
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...
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 ...
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...
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...
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...
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...
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...
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...
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...
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 ...
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...
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...
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...
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...
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...
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 ...
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,...
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�...
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...
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:...
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...
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 ...
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...
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...
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...
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...
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...
December 2023—LGC Clinical Diagnostics has launched Seraseq unmethylated and methylated ctDNA mutation mixes for assay development, validation, and routine performance monitoring. Key features ...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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. �...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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 ...
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...
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...
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 ...
Webinar presenters ALEXANDER CRAIG MACKINNON, JR, MD, PHD, Professor, Department of Pathology, University of Alabama at Birmingham, DARSHAN CHANDRASHEKAR, PHD, Assistant Professor, Department of ...
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....
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...
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...
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...
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...
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...
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. ...
November 2023—Bio SB has launched a fully automated immunohistochemistry platform for deparaffinization and antigen retrieval and staining. Applications include immunohistochemistry, Mohs IHC, ...
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...
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 ...
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...
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...
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...
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...
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...
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 ...
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...
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...
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 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...
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...
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 ...
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...
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...
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...
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...
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 ...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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 ...
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...
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 ...
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...
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...
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 ...
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...
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...
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...
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...
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 ...
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...
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...
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...
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...
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...
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...
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 ...
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...
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...
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 ...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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....
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...
Pathology/Laboratory Medicine/Laboratory Management
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...
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...
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...
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 ...
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...
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. ...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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. ...
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...
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...
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...
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...
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...
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...
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 ...
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...
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...
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 ...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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“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...
“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...
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...
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...
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...
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 ...
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...
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...
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...
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, 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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
August 2023—Climate control, calculation verification, block retention, and histocompatibility section director (technical supervisor) qualifications are among the areas in which laboratories c...
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....
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...
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...
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...
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...
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...
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...
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...
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 ...
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...
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 ...
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...
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 ...
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 ...
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...
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...
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...
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 ...
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...
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 .
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 .
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...
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...
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 ...
Webinar presenter GREG MILLER, PHD, Professor of Pathology, Director of Pathology Information Systems, Co-Director of Clinical Chemistry, Virginia Commonwealth University Health System, Richmond...
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...
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...
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...
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...
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...
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 ...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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 ...
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 ...
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...
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...
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. ...
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...
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...
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...
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...
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...
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...
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. ...
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...
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...
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 ...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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,...
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 ...
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,...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
300×250 The post Horiba_eNEWS_061223 first appeared on CAP TODAY .
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...
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 ...
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...
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...
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 ...
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 ...
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...
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...
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...
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 ...
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...
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...
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 ...