ZeptoMetrix launches NATtrol MS2 bacteriophage stock
January 2023—ZeptoMetrix launched its NATtrol MS2 bacteriophage quantitative stock, intended for use as an internal process control for rt-PCR assays.
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 HemoSonics Quantra with QStat cartridge
January 2023—HemoSonics has received FDA 510(k) clearance for the Quantra hemostasis system with QStat cartridge. The clearance of the QStat cartridge expands the Quantra system’s indications for use to include trauma and liver transplant procedures.
Hologic awarded contract from BARDA
December 2022—Hologic has been awarded a $19 million contract from the Biomedical Advanced Research and Development Authority. The funding will help bring Hologic’s Panther Fusion SARS-CoV-2/Flu A/B/RSV and Aptima SARS-CoV-2 assays in line with the FDA’s in vitro diagnostic standards and support clinical efforts to obtain claims for nasal samples using the Panther Fusion as well as market authorization for COVID-19 testing of asymptomatic individuals who have reason to be tested. The Aptima SARS-CoV-2 assay received EUA in May 2020, and the CE-marked Panther Fusion SARS-CoV-2/Flu A/B/RSV assay is under development in the United States. The project has been funded with federal funds from the U.S. Department of Health and Human Services, the Administration for Strategic Preparedness and Response, and BARDA.
FDA clears Nova’s blood glucose reference analyzer
December 2022—The FDA has cleared Nova Biomedical’s Nova Primary blood glucose reference analyzer. Nova Primary is designed to replace the YSI Stat Plus 2300 Glucose and L-Lactate analyzer, which has been discontinued by YSI.
FDA authorizes Abbott monkeypox test
December 2022—The FDA issued emergency use authorization to Abbott Molecular for the Alinity m MPXV, a real-time polymerase chain reaction test intended to detect monkeypox DNA using lesion swab specimens from individuals suspected of monkeypox virus infection. The test is intended for use by qualified clinical laboratory personnel specifically instructed and trained in the techniques of PCR and in vitro diagnostic procedures. Testing is limited to CLIA-certified laboratories that meet the requirements to perform moderate- or high-complexity tests.
Roche gets EUA for high-throughput monkeypox test
December 2022—Roche announced that the FDA has granted emergency use authorization for the Cobas MPXV for use on Cobas 6800/8800 systems. The real-time PCR test is for the qualitative detection of DNA from monkeypox virus in lesion swabs collected from individuals suspected of having monkeypox infection by their health care provider. The assay uses β-globin as an endogenous control to assess specimen adequacy. It detects monkeypox nucleic acids and the endogenous control in the same well.
MRC Holland launches two digital MLPA probe mixes
December 2022—MRC Holland released two assays, the Salsa digitalMLPA Probemix D006 Multiple Myeloma and Salsa digitalMLPA Probemix D007 Acute Lymphoblastic Leukemia.
Bio-Rad, NuProbe to develop digital PCR assays
December 2022—Bio-Rad Laboratories and NuProbe USA have entered into an agreement in which NuProbe will exclusively license its allele enrichment technologies to Bio-Rad for the development of multiplexed digital PCR assays. “Bio-Rad provides the leading solution for digital PCR, and we are committed to providing oncology researchers with technologies that enable everything from biomarker discovery to clinical trials and patient monitoring of minimal residual disease,” Simon May, EVP and president of Life Sciences at Bio-Rad, said in a joint press release. “We look forward to working with NuProbe USA to develop the next generation of highly multiplexed digital PCR assays as part of our expanding oncology offering.”
Sebia acquires Zeus Scientific
December 2022—Sebia announced the acquisition of Zeus Scientific, an in vitro diagnostic company based in Branchburg, NJ. Sebia, headquartered in Lisses, France, says the acquisition will expand its capabilities and product portfolio in autoimmunity and reinforce its operations and footprint in the United States. Financial terms of the agreement are undisclosed.
Primera slide, cassette printers
December 2022—Primera Technology showcased its Signature EVO slide and cassette printers at the National Society for Histotechnology convention.