ZeptoMetrix releases flu, RSV, SARS-CoV-2 external run control
December 2022—ZeptoMetrix has released its NATtrol external run control for flu A and B, RSV B, and SARS-CoV-2, for research use only.
Webinars and Sponsored Roundtables — Register Now
Wednesday, September 23, 2026. 12 PM-1 PM ET
Roundtable presenters Dr. David Sacks MB, ChB, FRCPath, Chairman, Steering Committee National Glycohemoglobin Standardization Program (NGSP), and Priya Sivaraman, PhD, Senior Technical Product Manager, Tosoh Bioscience.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
Thursday, September 24, 2026 11 AM-12 PM CT
This session explores the evolving role of RAS in precision oncology, from the biology of RAS mutations to the expanding landscape of targeted therapies. Through expert presentations, real-world case discussions, and interactive audience polling, participants will examine best practices for RAS biomarker testing across solid tumors, including lung, colorectal, and pancreatic cancers. The session will highlight practical considerations for tissue and liquid biopsy, strategies to address testing gaps, and the importance of multidisciplinary collaboration to ensure timely identification of patients who may benefit from RAS-targeted therapies.
Webinar presenters David Braxton, MD, Chief of Molecular Pathology Services, Hoag Family Cancer Institute & Hoag Memorial Hospital Presbyterian, and Carlos Becerra, MD, Research Director for Medical Oncology, Margaret Given Larkin Endowed Chair for Developmental Cancer Therapeutics, Hoag Memorial Hospital Presbyterian.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
Wednesday, September 30, 2026. 1 PM-1:30 PM ET
Roundtable presenters John Longshore, PhD, Head of Scientific Affairs, Global Oncology Diagnostics, AstraZeneca, and Flora Berisha, MS, Executive Director, Global Head of Diagnostic Partnering and Development, Johnson & Johnson Innovative Medicine, and Mark D. Ewalt, MD, Associate Medical Director for Laboratory Operations, Diagnostic Molecular Pathology, Molecular Diagnostics Service, Department of Pathology and Laboratory Medicine, Memorial Sloan Kettering Cancer Center, and Isabel Preeshagul, DO, MBS, Thoracic Medical Oncologist, Memorial Sloan Kettering Cancer Center.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
Tuesday, October 20, 2026 11 AM-12 PM ET
Hear experts review the biological and clinical significance of the HER2 expression continuum in breast tissue, providing a clearer understanding of how these variations might impact diagnosis, and discuss the emerging importance of documenting HER2-low and HER2-ultralow categories using a validated IHC assay.
Webinar presenters Keith Wharton, MD, PhD, Global Medical Affairs Leader–Pathology,
Roche Diagnostics Solutions, and Hannah Y. Wen, MD, PhD, Director, Breast Pathology Fellowship, Associate Team Leader, Breast Pathology Team, Attending Pathologist, Memorial Sloan Kettering Cancer Center.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
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FDA clears NanoZoomer S360MD slide scanner system
November 2022—Hamamatsu Photonics announced that the FDA granted 510(k) clearance to market the NanoZoomer S360MD high-throughput, automated slide scanner system for primary diagnostic use. It is intended to aid pathologists in reviewing and interpreting digital images of surgical pathology slides prepared from formalin-fixed, paraffin-embedded tissue.
Cofactor Genomics reports OncoPrism data
October 2022—Cofactor Genomics presented initial results from the PREDAPT (Predicting Immunotherapy Efficacy from Analysis of Pre-treatment Tumor Biopsies) multicenter clinical trial at the Advances in Genome Biology and Technology Precision Health Meeting in September. The company says its data show that Cofactor’s OncoPrism test using predictive immune modeling was nearly twice as accurate as PD-L1 assays in determining who will benefit from immunotherapies such as Keytruda (pembrolizumab).
Roche launches digital PCR system
October 2022—Roche launched its Digital LightCycler system, the company’s first digital polymerase chain reaction system, for precise DNA and RNA analysis in areas such as oncology and infectious diseases. The instrument features three unique reaction plates, six channel multiplexing capabilities, and a 5× concentrated master mix reagent. Run time is two to four hours with up to 96 samples per run.
FDA clears DiaSorin Simplexa COVID-19 test
October 2022—DiaSorin received 510(k) clearance from the FDA for its Simplexa COVID-19 Direct kit. The sample-to-answer test detects SARS-CoV-2 directly from nasopharyngeal or nasal swab specimens and is designed for use on the Liaison MDX system. The test targets two regions of the viral genome and results are available in a little over an hour.
StatLab TissueGuard processing gel
October 2022—StatLab has released TissueGuard, an agarose gel that stabilizes and protects small or fragile specimens during processing while allowing reagent penetration. TissueGuard can be used for cytology samples, including fine-needle aspirates, urine and nongynecological specimens, and other specimens using cell block preparation, and for histology applications, including needle biopsies, nerves, small arteries, aggregates, lymph nodes, and small tissue fragments. The gel does not stain and remains invisible when blocks are cut.
Bio-Rad extends range of StarBright dyes
October 2022—Bio-Rad extended its range of StarBright dyes with the StarBright Violet 760, StarBright UltraViolet 575, and StarBright UltraViolet 605 dyes, to provide greater flexibility in multicolor flow cytometry panels. The company says the dyes offer improved brightness with narrow excitation and emission profiles for precise resolution, are resistant to photobleaching, and do not lose signal in fixation. They are compatible with the Bio-Rad ZE5 cell analyzer and S3e cell sorter and most flow cytometers without the need for special buffers.
FDA approves T-Cell Select to automate TB testing
October 2022—Oxford Immunotec, a division of PerkinElmer, announced FDA approval of its T-Cell Select reagent kit for automating the company’s T-Spot.TB test workflow for in vitro diagnostic use by certified laboratories.
Grenova releases study on reducing cost with pipette tip washer
October 2022—Grenova released a case study in which enzyme-linked immunosorbent assay validation was performed with pipette tips that were washed and reused five times using the company’s Tipnovus system. Grenova says its technology decreased overall cost per clinical diagnostic test, resulting in an increased profitability margin, and that the laboratory also decreased plastic waste.
Verichem reference materials for protein assays
October 2022—Verichem Laboratories offers liquid-stable, ready-to-use clinical reference materials for protein testing. The multilevel and combined Total Protein/Albumin Standard Kit, along with the optional and standalone level F, and the Microprotein Standard Kit are designed and manufactured for the calibration and calibration verification of albumin and total protein assays on a range of clinical testing systems, including from Abbott Diagnostics, Beckman Coulter, Roche Diagnostics, and Siemens Healthineers.