Sysmex adds CellaVision DC-1 to portfolio
February 2021—Sysmex America has added the FDA 510(k)-cleared CellaVision DC-1 to its portfolio of CellaVision products for low-volume hematology labs.
Webinars and Commercial Conversations — Register Now
Tuesday, November 10, 2026, 1:00 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 Samuel Caughron, MD, FCAP, Chief Strategy Officer, MAWD Pathology, Medical Director of Laboratory, AdventHealth Kansas City, Medical Director of Laboratory, Labcorp, President, Member & Director, Pathology Ventures, LLC
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
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
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Sanger Institute’s COSMIC database licensed via Qiagen
February 2021—Qiagen announced that it now retains the exclusive rights to license and distribute the COSMIC database from the Wellcome Sanger Institute for commercial use, effective Jan. 1. COSMIC, the Catalogue of Somatic Mutations in Cancer, is a large, comprehensive resource for exploring the impact of somatic mutations in human cancer. The database is updated continuously and contains more than 37 million coding mutations. More than 20,000 researchers, bioinformaticians, and clinicians worldwide use COSMIC, which is available for download, annotation, and integration.
PerkinElmer acquires Horizon, gets EUA for sample pooling
February 2021—PerkinElmer and Horizon Discovery have reached an agreement in which PerkinElmer will acquire Horizon for about $383 million.
Bilirubin calibrator, standard kits
February 2021—Verichem Laboratories released a liquid-stable, protein-based BR2 Bilirubin Calibrator designed for the calibration of Advanced Instruments’ Advanced BR2 Bilirubin Stat Analyzer. The product has an open-vial stability claim of five days and an unopened shelf-life claim of 14 months at 2° to 8°C. The bilirubin calibrator is packaged in amber serum vials with rubber-lined closures and contains 5.0 mL of standard material, with two vials per kit.
TTF1, napsin A tests for lung cancer diagnostics
February 2021—Novodiax launched two rapid IhcDirect antibody assays, TTF1 and napsin A, for in vitro diagnostic use.
FDA authorizes OTC at-home test for COVID-19
January 2021—The FDA issued an emergency use authorization for the first over-the-counter, at-home diagnostic test for COVID-19. The Ellume COVID-19 Home Test is a rapid, lateral flow antigen test that detects fragments of proteins of the SARS-CoV-2 virus using a mid-turbinate nasal swab sample from any person two years of age or older. The Ellume home test correctly identified 96 percent of positive samples and 100 percent of negative samples in people who had symptoms. In people without symptoms, the test correctly identified 91 percent of positive samples and 96 percent of negative samples. The home test uses an analyzer that connects with a software application on a smartphone to help users perform the test and interpret results. Results are delivered in as little as 20 minutes via a person’s smartphone. “By authorizing a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test, and find out their results in as little as 20 minutes,” FDA commissioner Stephen M. Hahn, MD, said in a statement released by the agency. “As we continue to authorize additional tests for home use, we are helping expand Americans’ access to testing, reducing the burden on laboratories and test supplies, and giving Americans more testing options from the comfort and safety of their own homes.”
GenMark ePlex RP2 panel receives EUA
January 2021—GenMark Diagnostics received FDA emergency use authorization for its ePlex Respiratory Pathogen Panel 2. The test provides results in less than two hours for more than 20 viruses and bacteria that cause respiratory infections, including COVID-19, flu, bronchitis, and the common cold.
Nova Biomedical blood glucose reference analyzer
January 2021—Nova Biomedical announced the availability of Nova Primary, a rapid blood glucose laboratory analyzer. Nova Primary fills the need for a glucose reference analyzer to replace the YSI Stat Plus 2300 Glucose and L-Lactate analyzer, which, as of July 2021, will no longer be supported by YSI, Inc.
Qiagen fully acquires NeuMoDx Molecular
January 2021—Qiagen has acquired the remaining 80.1 percent of NeuMoDx Molecular for $248 million in cash. The company purchased a 19.9 percent stake in NeuMoDx in 2018, along with the right to acquire the remaining stake. As part of the 2018 deal, Qiagen has distributed the NeuMoDx 288 and NeuMoDx 96 platforms in Europe and other markets outside the United States.
Verichem Labs offers data reduction services
January 2021—Verichem Laboratories is offering its customers free access to the company’s online, web-based data reduction services. Designed for use with Verichem’s products, the service supports the necessary statistics required within the clinical laboratory to satisfy current CLIA and CAP requirements for the calibration verification of clinical assays.