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Beckman Coulter Gets Emergency Use Authorization from FDA for Second Coronavirus Antibody Test

NEW YORK — Beckman Coulter said on Friday that its Access SARS-CoV-2 Immunoglobulin M (IgM) assay has received Emergency Use Authorization (EUA) from the US Food and Drug Administration.

The test is designed to detect IgM antibodies against SARS-CoV-2 and has demonstrated 99.9 percent specificity and 98.3 percent sensitivity, according to Beckman Coulter, which is part of Danaher. The assay can be used in random-access mode and runs on a range of the company's analyzers, including the high-throughput DxI 800 instrument, the DxI 600 analyzer for mid-sized labs, and the DxI 600i and Access 2 instruments for small labs and healthcare clinics.

Earlier this month, Beckman Coulter received EUA from the FDA for its Access Interleukin-6 immunoassay, which is designed to help physicians identify a severe inflammatory response and determine the risk of intubation with mechanical ventilation in COVID-19 patients. In June, the Brea, California-based company received FDA EUA for its Access SARS-CoV-2 IgG assay for the detection of immunoglobulin G against the virus.

Beckman Coulter said it is currently developing a SARS-CoV-2 antigen assay, as well as a quantitative IgG assay slated for launch later this year.