CEMI - FDA rejects Chembio' EUA application for rapid antibody test panel

Chembio Diagnostics (CEMI) slips 11% in premarket, as the FDA has declined to review the company's emergency use authorization ((EUA)) application for a rapid antibody test system, DPP SARS-CoV-2 IgM/IgG.The letter cited that the review of the IgM/IgG request is not a priority because, authorization of the test would have relatively limited impact on testing accessibility or testing capacity.The company said that the response letter has no effect on its pending request submitted in October, for an EUA for the DPP SARS-CoV-2 antigen test system.Recently, Chembio was awarded a $12.7M contract to support the development and pursuit of FDA EUA for DPP antigen test.

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FDA rejects Chembio' EUA application for rapid antibody test panel