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GenMark Gets FDA OK for Respiratory Virus Panel

NEW YORK (GenomeWeb News) – GenMark Diagnostics has received US Food and Drug Administration 510(k) clearance for its eSensor Respiratory Virus Panel.

The test simultaneously detects and differentiates 14 clinically relevant viruses from patients with influenza-like illness. According to GenMark, it has the "potential to significantly improve patient care by delivering superior co-infection detection, distinguishing rhinovirus from enteroviruses and identifying clinically relevant adenoviruses."

The test runs on the firm's eSensor XT-8 system.

The RVP test is the fourth FDA-cleared molecular diagnostic for GenMark, joining the firm's cystic fibrosis genotyping test, warfarin sensitivity test, and thrombophilia risk test. The Carlsbad, Calif.-based firm also is developing a hepatitis C virus test and a 2C19 test.

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