Unyvero System gets de novo clearance
June 2018—Curetis has been granted de novo clearance by the FDA to market the Unyvero System and Lower Respiratory Tract Infection Application Cartridge in the U.S.
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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ConfirmMDx included in EAU guidelines
June 2018—MDxHealth announced that its ConfirmMDx is included in the 2018 European Association of Urology guidelines. Inclusion in the guidelines will facilitate adoption of the test in EU member state-specific guidelines, and the company will pursue CE marking of the test.
Enzo validated antibodies for IHC
June 2018—Enzo Life Sciences introduced three clinically relevant antibodies for immunohistochemistry detection.
Nova Biomedical opens subsidiary in Switzerland
June 2018—Nova Biomedical has opened a sales and after-sales support subsidiary in the canton of Zug, outside of Zurich.
Thermo Fisher inks deal to expand Oncomine Dx
June 2018—Thermo Fisher Scientific has signed agreements with Daiichi Sankyo and Takeda Pharmaceuticals designed to expand the clinical utility of Oncomine Dx Target Test in support of clinical trials and drug development programs at the Japanese companies.
Sanquin selects Alinity s for blood, plasma screening
June 2018—Sanquin and Abbott announced they signed a multiyear contract for the supply of primary serological equipment and consumables, including Abbott’s Alinity s system, for blood and plasma screening.
Validate body fluids kit
June 2018—LGC Maine Standards released its Validate Body Fluids, a comprehensive body fluids kit for linearity and calibration verification.
FDA authorizes Dexcom G6 CGM system
June 2018—The FDA has granted a de novo request to Dexcom for its Dexcom G6 integrated continuous glucose monitoring system for determining blood glucose levels for people with diabetes ages two and older.
MilliporeSigma launches flow cytometer
June 2018—MilliporeSigma launched its CellStream flow cytometry system at the CYTO 2018 conference, April 28–May 2, in Prague. The CellStream is a benchtop, customizable flow cytometer that uses a camera for detection.
SPE product for urine drug testing
June 2018—Phenomenex introduced Strata-X-Drug B Plus, a solid-phase extraction sample preparation product for urine drug testing in clinical and forensic toxicology laboratories.