GenMark secures EUA for multiplex test

2020 10 09 22 47 9693 Fda Button 400

The U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to GenMark Diagnostics for its ePlex respiratory pathogen panel 2 (RP2) test. The test provides results for more than 20 viruses and bacteria that can cause serious respiratory infections including COVID-19, the flu, bronchitis, and the common cold.

In less than two hours, the ePlex RP2 test can identify or rule out the responsible pathogen or pathogens to ensure proper treatment. The ePlex RP2 panel is designed for use with the firm's ePlex system, along with the ePlex RP panel and blood culture identification (BCID) panels (Gram-positive, Gram-negative, and fungal pathogens).

The ePlex RP2 panel also has the CE Mark.

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