FDA clears Simplexa Congenital CMV Direct assay
Nov. 11, 2022—DiaSorin announced it has received FDA 510(k) clearance for its Simplexa Congenital CMV Direct kit.
Webinars and Sponsored Roundtables — Register Now
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
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Industry News
ZeptoMetrix launches NATtrol MS2 bacteriophage stock
Nov. 10, 2022—ZeptoMetrix launched its NATtrol MS2 Bacteriophage quantitative stock, intended for use as an internal process control for rt-PCR assays.
Roche introduces Cobas 5800 system
Nov. 9, 2022—Roche announced plans for the U.S. launch of the Cobas 5800 system, a compact, fully-automated molecular instrument that aims to offer a flexible, PCR testing solution to help clinicians diagnose infectious diseases.
Werfen to acquire Immucor
Nov. 4, 2022—Werfen announced it has agreed to acquire Immucor from asset management firm TPG.
Thermo Fisher Scientific buys Binding Site
Oct. 31, 2022—Thermo Fisher Scientific announced today that it has entered into a definitive agreement to acquire the Binding Site Group from a shareholder group led by European private equity firm Nordic Capital.
Bio-Rad launches Exact Diagnostics CT/NG, STI run controls
Oct. 28, 2022—Bio-Rad Laboratories has launched two Exact Diagnostics products, CT/NG Positive Run Control, intended to be used with Chlamydia trachomatis and Neisseria gonorrhoeae molecular assays, and STI Negative Run Control, which monitors the absence of Chlamydia trachomatis and Neisseria gonorrhoeae in various molecular assays, the company says, and can be used to detect errors in laboratory testing procedures, including potential contamination events, while controlling for sample adequacy assessment.
FDA clears COVID-19 PCR test on Cobas 6800/8800 systems
Oct. 25, 2022—Roche announced that the FDA has granted 510(k) clearance for the Cobas SARS-CoV-2 Qualitative PCR test for use on the automated Cobas 6800 and Cobas 8800 systems.
ZeptoMetrix launches molecular QCs for women’s health
Oct. 19, 2022—ZeptoMetrix launched two vaginal molecular QC controls, NATtrol Vaginal Positive Control and NATtrol Vaginal Negative Control, for in vitro diagnostic use.
Indica, Hamamatsu to provide integrated DP workflows
Oct. 18, 2022—Indica Labs and Hamamatsu Photonics announced an agreement to maintain long-term interoperability between Indica Labs’ Halo AP software platform and Hamamatsu’s NanoZoomer series of scanners.
Sebia acquires Zeus Scientific
Oct. 17, 2022—Sebia announced the acquisition of Zeus Scientific, an in vitro diagnostic company based in Branchburg, NJ.