EUA, CE mark for Lyra Direct SARS-CoV-2 Assay
June 2020—Quidel announced it has received emergency use authorization for the Lyra Direct SARS-CoV-2 Assay from the Food and Drug Administration to allow direct sample processing.
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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Cascadion system launched with vitamin D test
May 2020—Thermo Fisher Scientific announced that its Cascadion SM clinical analyzer is commercially available in the U.S. with the Cascadion SM 25-Hydroxy Vitamin D assay. The Cascadion system analyzes samples directly from qualified primary blood collection tubes. The Cascadion SM 25-Hydroxy Vitamin D Assay incorporates fully barcoded components, all traceable to a specific result.
Nova webinar on COVID-19 bedside glucose management
May 2020—Nova Biomedical announced a webinar, titled “COVID-19 Bedside Glucose Management: Risk of Ascorbic Acid and Hematocrit Interference,” to help inform and support health care workers treating COVID-19 patients. The webinar, led by Charbel Abou-Diwan, PhD, director of Nova Biomedical’s medical and scientific affairs, examines the risk of inaccurate glucose meter results due to interference from ascorbic acid and anemia.
MedTest Dx FDA-approved quantitative test for G6PD
May 2020—MedTest Dx announced the availability of its Pointe Scientific–branded assay for the highly sensitive quantification of G6PD in whole blood.
Biocare launches seven IVD antibodies
May 2020—Biocare Medical launched seven novel IVD IHC antibody markers for clinical diagnostics and research applications. This launch focuses on several immuno-oncology markers, critical in aiding early-stage cancer drug developments and patient treatment.
COVID-19 proficiency testing
May 2020—The CAP has released a new proficiency testing program for the detection of SARS-CoV-2 by nucleic acid amplification testing.
EKF launches β-ketone, glucose POC analyzer
May 2020—EKF Diagnostics has launched in the United States its Stat-Site WB dual-use whole blood β-ketone and glucose meter for professional use in the management of diabetes. The CLIA-waived handheld analyzer quantitatively measures β-ketone (beta-hydroxybutyrate) from fresh capillary and venous whole blood in 10 seconds and delivers quantitative measurements in five seconds for glucose in fresh capillary, venous, and neonatal whole blood. The system has a measurement range of 0.1–8.0 mmol/L for β-ketone and 0.5–33.3 mmol/L for blood glucose. Its hematocrit range is 10–70 percent for β-ketone and 20–70 percent for blood glucose.
BD Kiestra ReadA device listed with the FDA
May 2020—BD announced that its BD Kiestra ReadA is device listed with the FDA. The BD Kiestra ReadA incubation and imaging system, which is available as a standalone instrument, aims to help improve operational efficiency in clinical microbiology laboratories by automating routine plate management tasks and delivering accuracy through standardized digital image acquisition. BD, 201-847-6800
MilliporeSigma to manufacture Elypta liquid biopsy kits
May 2020—MilliporeSigma has been selected by Swedish molecular diagnostics company Elypta as the contract manufacturer for Elypta’s clinical diagnostic liquid biopsy kits. The kits analyze metabolites deregulated in several cancer types and will initially be made available for research use only. They are intended for mass spectrometry systems and will allow qualified researchers to measure the full spectrum of human glycosaminoglycans in body fluid samples.
Viracor Eurofins gets EUA for SARS-CoV-2 LDT
May 2020—Viracor Eurofins was granted FDA emergency use authorization for the Viracor SARS-CoV-2 assay, a real-time polymerase chain reaction test intended for the qualitative detection of SARS-CoV-2 viral RNA in nasopharyngeal swab, nasal swab, nasopharyngeal wash, nasal wash, oropharyngeal swab, and bronchoalveolar lavage from individuals suspected of having COVID-19.