AMH assay kit gets FDA clearance
December 2018—Ansh Labs has received de novo FDA clearance for its MenoCheck picoAMH ELISA.
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
December 2018—Ansh Labs has received de novo FDA clearance for its MenoCheck picoAMH ELISA.
December 2018—LGC Maine Standards has released its Validate Body Fluids kit, 205bf. The kit, in a simulated body fluid matrix, will assist in the documentation of linearity, calibration verification, and verification of the reportable range for albumin, amylase, cholesterol, creatinine, glucose, lactate, lactate dehydrogenase, total protein 2, triglycerides, and urea nitrogen.
December 2018—Qiagen launched its QIAseq FastSelect RNA Removal Kit, which allows rapid selective removal of RNA classes from any sample, enabling researchers to attain high-quality, reproducible RNA sequencing results.
December 2018—A prospective study in patients with advanced non-small cell lung cancer has demonstrated that the blood-based Guardant360 assay, developed by Guardant Health, identified clinically actionable mutations in nearly twice as many patients as tissue biopsy alone.
December 2018—Australian health care company Primary Health Care has joined forces with Siemens Healthineers to deploy more than 70 Atellica Solution immunoassay and clinical chemistry analyzers.
December 2018—MDxHealth announced that the journal Urology Practice has published a study demonstrating the clinical utility of SelectMDx, a noninvasive liquid biopsy test to identify patients at increased risk of aggressive prostate cancer, in guiding initial prostate biopsy decision-making.
December 2018—LGC Maine Standards released its Validate CM2 linearity and calibration verification kit for Ortho Vitros analyzers.
December 2018—Magnolia Medical Technologies launched its new Best Practice Blood Culture Kit. The kit, developed in partnership with Aero-Med, includes the Steripath Gen2 Initial Specimen Diversion Device, two blood culture bottles, one ChloraSep antiseptic skin prep, and two alcohol prep pads.
December 2018—Precipio launched a new ICEme kit using the company’s proprietary Ice-Cold PCR technology. The kit provides physicians with the ability to use a liquid biopsy to identify patients eligible for tyrosine kinase inhibitor therapies through analysis of tumor DNA for these EGFR mutations.
November 2018—Detroit-based Henry Ford Health System Pathology and Laboratory Medicine announced a research and development partnership with Sakura Finetek USA to increase the automation level of its core anatomic pathology laboratories.