Roche gets clearance, CLIA waiver for POC Bordetella test
Dec. 2, 2025—Roche’s Cobas Liat Bordetella test for the detection of Bordetella infections, including pertussis, has been granted FDA 510(k) clearance and a CLIA waiver.
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
Dec. 2, 2025—Roche’s Cobas Liat Bordetella test for the detection of Bordetella infections, including pertussis, has been granted FDA 510(k) clearance and a CLIA waiver.
Dec. 1, 2025—The Centers for Medicare and Medicaid Services has finalized its pricing determination for Pillar Biosciences’ OncoReveal CDx.
Nov. 11, 2025—OGT launched the SureSeq Myeloid MRD Plus NGS panel, to detect ultra-low frequency variants in key measurable residual disease–associated biomarkers in acute myeloid leukemia.
Nov. 7, 2025—Randox Toxicology has launched its Nitazenes Array, an immunoassay designed to detect a broad spectrum of nitazene analogues from a single sample.
Nov. 6, 2025—Qiagen has entered into a definitive agreement to fully acquire Parse Biosciences, a provider of scalable, instrument-free solutions for single-cell research.
Nov. 5, 2025—Access25, a virtual event that featured live demos of Proscia Aperture, Proscia’s latest product offering that surfaces patient insights at the moment of diagnosis, is now available on demand by registering at Proscia.com.
Nov. 4, 2025—The FDA has granted QuidelOrtho Corp. 510(k) clearance for the Vitros hs Troponin I Reagent Pack.
Nov. 3, 2025—BD has received FDA 510(k) clearance and CE marking for its Enteric Bacterial Panel and Enteric Bacterial Panel Plus for the BD Cor system.
Oct. 17, 2025—Bio-Rad Laboratories has launched an enhanced version of its Liquichek opiate control.
Oct. 16, 2025—The FDA has cleared Roche’s Elecsys pTau181 test, a blood-based biomarker test indicated as an aid in the initial assessment for Alzheimer’s disease and other causes of cognitive decline in the primary care setting.