Siemens HbA1c test now available on Atellica Solution
May 16, 2019—Siemens Healthineers announced the worldwide availability of its Atellica CH Enzymatic Hemoglobin A1c (A1c_E) Assay to assist clinicians in diagnosing and monitoring diabetes.
Webinars and Sponsored Roundtables — Register Now
Tuesday, April 28, 2026, 12:00 PM–1:00 PM ET
Discover how next-day comprehensive genomic profiling (CGP) is possible with the Oncomine Comprehensive Assay Plus on the Genexus System—delivering both speed and accuracy.
Webinar presenters Jane Bayani, MHSc, PhD, Assistant Professor and Co-Director, Diagnostic Development, Ontario Institute for Cancer Research, Canada, and Nicola Normanno, MD, Scientific Director, IRCCS Romagnolo Institute for the Study of Tumors, Italy, and Morten Grauslund, PhD, Molecular Biologist, Department of Pathology, Rigshospitalet/Copenhagen University Hospital, Copenhagen, Denmark.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
CAP TODAY does not endorse any of the products or services named within. The webinar is made possible by a special educational grant from Thermo Fisher Scientific. For Research Use Only. Not for use in diagnostic applications.
Thursday, April 30, 2026, 11:00 AM–12:00 PM ET
Hear an expert discuss how Memorial Sloan Kettering Cancer Center (MSKCC) is utilizing
the oncoReveal® Nexus 21-gene panel to redefine turnaround time and actionable insights
in cancer care. Dr. Ewalt shares a perceptive look at the clinical need for rapid, front-line NGS sequencing, and how a unique, purpose built targeted NGS panel (Pillar Biosciences’ oncoReveal Nexus 21 gene Panel) was developed, validated and implemented clinically by Memorial Sloan Kettering Cancer Center (MSK-REACT) to complement their current comprehensive genomic profiling (CGP) approach.
Webinar presenter Mark Ewalt, MD, Associate Medical Director for Laboratory Operations for Diagnostic Molecular Pathology in the Molecular Diagnostics Service, Department of Pathology and Laboratory Medicine, MSKCC.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
CAP TODAY does not endorse any of the products or services named within. The webinar is made possible by a special educational grant from Pillar Biosciences.
Thursday, May 28, 2026, 1:00–2:00 PM ET
This session is designed to improve understanding and application of recent updates to synoptic pathology reporting protocols such as the latest Reporting Template for Reporting Results of Biomarker Testing of Specimens from Patients with Carcinoma of the Breast. These changes reflect evolving clinical guidelines that directly influence diagnostic accuracy and treatment selection in breast cancer care.
Webinar presenters Thaer Khoury, MD, FCAP, Chair, Pathology and Laboratory Medicine, Roswell Park Comprehensive Cancer Cente, and Colin Murphy, CEO of mTuitive.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
Subspecialties
Interactive Product Guides
Industry News
DxA 5000 total lab automation solution CE marked
May 9, 2019—Beckman Coulter announced that its DxA 5000 total laboratory automation solution has achieved the CE mark and China Food and Drug Administration approval. The DxA 5000 aims to deliver rapid and consistent turnaround time, provide a new level of comprehensive preanalytical sample quality detection, and reduce the number of manual processing steps.
HemoSonics Quantra QPlus system gets de novo clearance
May 3, 2019–HemoSonics announced that its Quantra Hemostasis Analyzer platform and QPlus cartridge have been granted de novo marketing authorization by the FDA and are available for sale in the United States.
FDA expands use of pembrolizumab for NCSLC
May 1, 2019—The Food and Drug Administration approved pembrolizumab (Keytruda, Merck) for the first-line
BD Bactec platelet QC media FDA-cleared, CE-IVD marked
April 29, 2019—BD announced the worldwide availability of BD Bactec platelet quality control media to identify contaminated platelet units. The product can be used for quality control testing of leukocyte reduced apheresis platelet units—leukocyte reduced single and a pool of up to six units of leukocyte reduced whole blood platelet concentrates.
Roche launches Ventana HER2 Dual ISH DNA probe assay
April 25, 2019—Roche announced the launch of the Ventana HER2 Dual ISH DNA Probe Cocktail assay to detect the HER2 biomarker in breast and gastric cancer patients to aid in determining who might be eligible for the targeted drug trastuzumab (Herceptin, Roche).
Beckman Coulter’s Early Sepsis Indicator gets 510(k) clearance
April 22, 2019—Beckman Coulter announced that its Early Sepsis Indicator has received 510(k) clearance from the U.S. Food and Drug Administration. The Early Sepsis Indicator is a hematology-based cellular biomarker designed to help emergency department physicians identify patients with sepsis or who are at an increased risk of developing sepsis and is reported automatically as part of a routine CBC with differential test.
FDA approves Therascreen FGFR kit + erdafitinib
April 17, 2019—Qiagen announced the U.S. launch of its Therascreen FGFR RGQ RT-PCR Kit as a companion diagnostic to help guide the use of the FGFR kinase inhibitor Balversa (erdafitinib; Janssen Biotech). The test will aid in identifying patients with urothelial cancer whose tumors have certain alterations in the fibroblast growth factor receptor 3 gene. The FDA co-approved the test with Balversa.
FDA clears Ortho’s Vitros XT MicroSlides
April 11, 2019–Ortho Clinical Diagnostics’ Vitros XT MicroSlides have been cleared by the FDA. The product features multitest technology that allows laboratories to run two tests simultaneously on one MicroSlide.
Roche launches Navify Mutation Profiler, Therapy Matcher
March 27, 2019—Roche announced the CE-IVD mark and launch of its Navify Mutation Profiler, clinical software that provides annotation, interpretation, and clinical reporting