Hardy Dx gets breakthrough designation for AMR assays
Feb. 18, 2026—The Food and Drug Administration has granted breakthrough device designation to the NG-Test Candida auris and NG-Test Acineto-5 assays.
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
Feb. 18, 2026—The Food and Drug Administration has granted breakthrough device designation to the NG-Test Candida auris and NG-Test Acineto-5 assays.
Feb. 17, 2026—Cepheid received FDA clearance for its Xpert GI panel, a multiplex PCR test designed to detect gastrointestinal pathogens from a single patient sample.
Feb. 6, 2026—Fujirebio and Sysmex have agreed on a sales collaboration in which Sysmex will exclusively sell Fujirebio’s fully automated Lumipulse immunoassay systems and reagents for dementia testing.
Feb. 5, 2026—The Food and Drug Administration has granted 510(k) clearance for Randox USA’s clinical drug testing panel.
Feb. 4, 2026—Congress passed yesterday a five-bill package called the Consolidated Appropriations Act of 2026, ending the partial government shutdown that began on Jan. 31.
Jan. 21, 2026—Zepto Life Technology has launched the FungiFlex Mold panel.
Jan. 28, 2026—Fujirebio launched the Lumipulse G pTau 217 CSF assay for the fully automated Lumipulse G immunoassay analyzers.
Jan. 27, 2026—Fujifilm Healthcare Americas Corp. and Voicebrook are partnering to integrate Voicebrook’s VoiceOver Pro with Fujifilm’s Synapse Pathology, a picture archiving and communication system designed to streamline case management.
Jan. 26, 2026—The Food and Drug Administration has approved Guardant Health’s Guardant360 CDx as a companion diagnostic to identify patients with BRAF V600E-mutant metastatic colorectal cancer who may benefit from treatment with encorafenib (Braftovi, Pfizer) in combination with cetuximab and chemotherapy in accordance with the approved product labeling.
Jan. 13, 2026—Biocartis has entered into a research collaboration with Mayo Clinic to develop a rapid sample-to-answer test aiming to decrease the time to treatment for breast cancer patients.