NEW YORK (GenomeWeb News) – GenMark Diagnostics today said that it has filed with the US Food and Drug Administration for 510(k) clearance of its Respiratory Viral Panel.
The test would run on the firm's eSensor XT-8 and is designed to identify multiple viruses from patients exhibiting symptoms of respiratory infection. The Carlsbad, Calif.-based firm previously stated that the test would detect 21 upper respiratory viruses.
During the firm's third-quarter conference call last month, GenMark President and CEO Hany Massarany said that the company expects the RVP test to be cleared before next year's flu season.
If the test is cleared in the US it will join three other FDA-cleared tests sold by the company: a cystic fibrosis genotyping test, a warfarin sensitivity test, and a thrombophilia risk test.