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 Sponsored Roundtables — Register Now
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
Wednesday, June 24, 2026, 12:00–1:00 PM ET
Hear an expert discuss the expanded clinical utility of HER2 IHC scoring in metastatic breast cancer and its impact on your practice
Webinar presenters Michelle Shiller, DO, AP, CP, MGP, FACP, Baylor University Medical Center.
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.
Reduced TAT for Vivalytic SARS-CoV-2 positive samples
February 2021—Randox announced that its improved software for the Vivalytic analysis device enables its CE-marked Vivalytic SARS-CoV-2 rapid coronavirus test to deliver results for positive samples in less than 30 minutes.
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.