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GenMark Diagnostics Receives CE Mark for Respiratory Panel Including SARS-CoV-2, Flu

NEW YORK ─ GenMark Diagnostics said on Monday that it has received the CE mark for the ePlex Respiratory Pathogen Panel 2 (RP2), enabling its use in Europe and other regions that accept the designation.

Carlsbad, California-based GenMark said the multiplexed molecular test provides results in less than two hours for more than 20 viruses and bacteria that cause common and often serious respiratory infections, including SARS-CoV-2, influenza A and B, respiratory syncytial virus, and rhinovirus. RP2 provides results for infections with similar symptoms such as fever, cough, and body aches, a critical capability as the flu season coincides with the COVID-19 pandemic, GenMark said.

"Syndromic testing will be vital in helping healthcare professionals accurately diagnose seriously ill patients with similar symptoms, speeding up treatment and helping improve resource management," Scott Mendel, president and CEO of GenMark, said in a statement.

In March, the company received an award of $749,000 to develop RP2 from the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA). GenMark submitted the panel for US Food and Drug Administration Emergency Use Authorization in June and, in parallel, began distributing the product in the US for clinical use.

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