Public Health Emergency - Leading a Nation Prepared
BARDA is partnering with GenMark DX to develop an accurate, rapid coronavirus diagnostic for use in clinical and hospital labs. BARDA’s support follows a March 19 decision by the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of the GenMark’s ePlex SARS-CoV-2 test to detect SARS-CoV-2 in samples collected from people suspected of being infected with COVID-19.
Development undertaken with BARDA support should allow the company to complete the necessary studies to request FDA clearance of the ePlex® Respiratory Pathogen v2 Panel to detect SARS-CoV-2 and other pathogens. This fifth BARDA-supported test increases domestic capacity in the current pandemic and any future outbreaks. Early, accurate diagnoses are essential to treating the infection and curbing the spread of disease.
BARDA will provide up to $749,000 of the total $1.4 million estimated development cost; GenMark will fund the remaining development costs.
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