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 Commercial Conversations — Register Now
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
Wednesday, November 18, 2026, 12:00 PM-1 PM ET
Join leading pathology experts, Savitri Krishnamurthy, MD, and Marilyn Bui, MD, PhD, for a webinar exploring potential challenges in HER2 IHC testing for breast cancer, emerging evidence supporting digital and computational pathology as assistive tools for pathologists in HER2 IHC assessment, and practical considerations for real-world implementation and adoption.
Webinar presenters Savitri Krishnamurthy, MD, Professor of Pathology, Department of Anatomical Pathology The University of Texas MD Anderson Cancer Center, Houston, Texas, and Marilyn Bui, MD, PhD, Surgical Pathologist and Cytopathologist Member and Professor, Departments of Pathology, Machine Learning, and Translational Pathology, Scientific Director, Analytic Microscopy Core Chair, Women in Oncology Executive Board Moffitt Cancer Center, Tampa, Florida
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 speakers are being compensated for their presentations. The program is not CME accredited and may not be used for CME credit.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
Wednesday, December 9, 2026, 12 PM-1 PM ET
Hear an expert pathologist discuss the role of HER2 IHC testing and scoring in solid tumors including endometrial, ovarian, cervical, bladder, non-small cell lung, colorectal, and biliary cancers
Webinar presenter Michelle Shiller, DO, MSPT, Baylor Sammons Cancer Center; Fulgent Genetics; Texas Cancer Interception Institute
CAP TODAY does not endorse any of the products or services named within. This program is intended for US healthcare professionals. This program is being sponsored by 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.