Simplexa COVID-19, flu A/B assay assay gets CE mark
Sept. 21, 2021—DiaSorin Molecular announced that it has CE marked its Simplexa COVID-19 and Flu A/B Direct kit.
Webinars and Sponsored Roundtables — Register Now
Thursday, October 29, 2026, 1 PM-2 PM ET
Hear an expert discuss the evolving role of PD-L1 testing in HNSCC and ovarian cancer.
Webinar presenter Georgios Deftereos, MD, Professor of Pathology, Associate Director of the Clinical Cancer Genomics Laboratory, Director of Molecular Cytopathology, University of California, San Francisco
CAP TODAY does not endorse any of the products or services named within. The webinar is made possible by a special educational grant from Agilent.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
Tuesday, November 3, 2026, 1 PM-2 PM ET
Hear an expert discuss the challenges of detecting NRG1 fusions and how RNA-based testing can support more comprehensive fusion identification in clinical practice.
Webinar presenter Benjamin Weinberg, MD, Associate Professor of Medicine and Attending Physician
specializing in gastrointestinal medical oncology
CAP TODAY does not endorse any of the products or services named within. The webinar is made possible by a special educational grant from Diaceutics.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
Tuesday, November 10, 2026, 1 PM-2 PM ET
Join us for a session to help improve diagnostic accuracy in your practice when scoring HER2 IHC 0 with faint, incomplete membrane staining in ≤10% of tumor cells vs IHC 0 with no membrane staining detected in patients with mBC.
Webinar presenter Jeffrey Gregg, MD, University of Nevada
CAP TODAY does not endorse any of the products or services named within. This program is being sponsored by Daiichi Sankyo, Inc. and AstraZeneca. The speaker is being compensated for the presentation. The program is not CME accredited and may not be used for CME accreditation.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
Monday, November 16, 2026, 12:30 PM-2 PM ET
Hear experts discuss a multidisciplinary approach to oncopathology for HER2
assessments for solid tumors in the absence of a companion diagnostic.
Webinar presenters Funda Meric-Bernstam, MD, Chair, Department of Investigational Cancer Therapeutics Medical Director, Institute for Personalized Cancer Therapy, The University of Texas MD Anderson Cancer Center, Houston, Texas, and Emina E. Torlakovic, MD, PhD, College of Medicine, University of Saskatchewan, Canadian Biomarker Quality Assurance, Saskatoon, Saskatchewan, Canada, and Carol Cheung, MD, PhD, JD, FRCPC, Deputy Director, Canadian Biomarker Quality, Assurance—Programme canadien d’assurance de la qualité des biomarqueurs
CAP TODAY does not endorse any of the products or services named within. This program is being sponsored by Daiichi Sankyo, Inc. and AstraZeneca. The speaker is being compensated for the presentation. The program is not CME accredited and may not be used for CME accreditation.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
Subspecialties
Interactive Product Guides
Industry News
FDA clears test that differentiates bacterial, viral infections
Sept. 20, 2021—MeMed announced FDA 510(k) clearance for use of the company’s MeMed BV test on the MeMed Key platform to help health care providers distinguish between bacterial and viral infections.
PreciseMDX introduces digital health platform
Aug. 31, 2021—PreciseMDX introduced a cloud-based solution that enables labs to set up scalable, personalized, digital experiences.
Visby gets FDA clearance, CLIA waiver for POC STI test
Aug. 30, 2021—Visby Medical announced it has received FDA 510(k) clearance and was granted a CLIA waiver to market its single-use PCR diagnostic test for the multiplexed detection of sexually transmitted infections caused by Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis using a self-collected vaginal swab.
FDA approves Oncomine Dx Target test as a CDx for Tibsovo
Aug. 27, 2021—The FDA has granted premarket approval to Thermo Fisher Scientific’s Oncomine Dx Target test as a companion diagnostic to identify patients with isocitrate dehydrogenase-1 mutated cholangiocarcinoma who may be candidates for Tibsovo (ivosidenib tablets).
BD launches high-throughput molecular dx platform in the U.S.
Aug. 26, 2021—BD has launched its FDA-approved BD COR PX/GX system, a fully automated, high-throughput diagnostic platform that integrates robotics and sample management software algorithms to automate the complete molecular laboratory workflow from sample processing to diagnostic test result.
FDA grants marketing authorization to Siemens ELF test
Aug. 25, 2021—Siemens Healthineers announced that its Enhanced Liver Fibrosis test was granted marketing authorization under the de novo review pathway.
Hardy Diagnostics releases group A strep agar
Aug. 24, 2021—Hardy Diagnostics has released its HardyChrom Group A Strep agar, a chromogenic medium recommended for the selective cultivation and differentiation of group A streptococcus from clinical specimens.
Siemens launches two Sysmex hemostasis systems
Aug. 16, 2021—Siemens Healthineers has launched Sysmex’s CN-3000 and CN-6000 hemostasis systems for mid- and high-volume coagulation testing.
Bio-Rad launches SARS-CoV-2 S gene variant controls
Aug. 13, 2021—Bio-Rad Laboratories has launched SARS-CoV-2 S gene alpha, beta, gamma, and epsilon variant controls.