BioFire SpotFire Vaginitis panel gets 510(k) clearance, CLIA waiver
Oct. 23, 2026—BioMérieux’s BioFire SpotFire Vaginitis panel has received FDA 510(k) clearance and CLIA waiver.
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
Pillar launches NGS panel to support MRD detection in AML
Oct. 22, 2026—Pillar Biosciences launched the MRDTect NPM1 and FLT3 ITD panel, a research use only, kitted NGS panel for measurable residual disease detection in acute myeloid leukemia.
WHO grants EUL for BioFire Global Fever Special Pathogens panel
Oct. 21, 2026—The World Health Organization has granted emergency use listing for the BioFire Global Fever Special Pathogens panel.
Agilent to acquire Proscia for up to $270 million
Oct. 13, 2026—Agilent Technologies has entered into a definitive agreement to acquire Proscia in an all-cash transaction valued at $240 million at closing and up to an additional $30 million based on achieving future performance milestones.
Horiba Yumizen H550 hematology analyzer gets 510(k) clearance
Oct. 5, 2026—Horiba’s Yumizen H550 hematology analyzer has received FDA 510(k) clearance for in vitro diagnostic use in clinical laboratories.
Siemens Healthineers launches Innovance D-Dimer 2.0 assay
Sept. 30, 2026—Siemens Healthineers has launched its CE-marked, FDA 510(k)-cleared Innovance D-Dimer 2.0 assay.
FDA clears Cepheid Xpert Respiratory panel
Sept. 29, 2026—Cepheid has received FDA clearance for the Xpert Respiratory panel, a multiplex PCR test designed to detect 13 common viral and bacterial respiratory pathogens from a single nasopharyngeal swab sample.
FDA clears QIAstat-Dx bacteria detection panel
Sept. 28, 2026—The Food and Drug Administration has cleared Qiagen’s QIAstat-Dx BCID GN Plus AMR panel.
Project Santa Fe Foundation adds three board members
Sept. 18, 2026—Project Santa Fe Foundation and Clinical Lab 2.0 have added three new members to its board of directors: Mercè Jordà, MD, PhD, MBA, chair of pathology and laboratory medicine, University of Miami Miller School of Medicine; William G. Morice, MD, PhD, president and CEO, Mayo Collaborative Services/Mayo Clinic Laboratories; and Peter Weir, MD, MPH, chief population health officer, University of Utah Health.
BioFire respiratory panels get IVDR class D CE mark
Sept. 17, 2026—BioMérieux’s BioFire Respiratory 2.1 Plus and BioFire FilmArray Pneumonia Plus panels have received the CE mark under the IVDR as class D in vitro diagnostic devices, the highest risk classification under the regulation.