10.03.2021 13:14:16
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Luminex Submits EUA For Flu A/B & RSV+SARS-CoV-2 Assay To FDA
(RTTNews) - Luminex Corporation (LMNX) announced that it has submitted Emergency Use Authorization application to the U.S. Food and Drug Administration for the company's new Aries Flu A/B & RSV+SARS-CoV-2 assay.
The Aries Flu A/B & RSV+SARS-CoV-2 assay, from a single test, detects and differentiates respiratory pathogens including influenza A virus, influenza B virus, respiratory syncytial virus (RSV), and ARS-CoV-2 virus and can be run on the company's molecular diagnostics platforms, Luminex Aries Systems.
This new combined assay, developed in partnership with Biomedical Advanced Research and Development Authority (BARDA), is expected to detect new variants of the coronavirus.
"It is critical to continue expanding the number of FDA-authorized assays that include SARS-CoV-2 detection for a broad range of clinical uses, and we're proud to have developed a single assay that provides answers about some of the most common respiratory infections - including SARS-CoV-2 - in just two hours" said Nachum "Homi" Shamir, Chairman, President and CEO of Luminex.
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