First Swine Flu test nod goes to Quest Diagnostics

July 27, 2009 by MassDevice staff

The race to be the first to get a diagnostic test for Swine Flu to market tipped to Quest Diagnostics, after the Food & Drug Administration gave emergency use authorization to one of its subsidiary's H1N1 influenza virus tests.

The Influenza A H1N1 (2009) Real Time RT-PCR test, made by Cypress, Calif.-based Quest unit Focus Diagnostics, is the first commercial lab test to win the emergency use nod from the FDA and the first to use Swine Flu RNA in nasal or throat samples to make the diagnosis, according to Quest. Turnaround time for the test is typically 24 hours, the company said.

The news is a blow to Waltham, Mass.-based Inverness Medical Innovations, London's Osmetech (which has local operations in Maynard, Mass.) and Kansas City-based Evogen Inc. All three were hoping to have their Swine Flu tests win favor from the FDA.

It's especially bitter medicine for Osmetech, which asked the FDA for emergency dispensation for its own molecular diagnostic for Swine Flu in May.

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