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Home » The first Swine Flu test nod goes to Quest Diagnostics

The first Swine Flu test nod goes to Quest Diagnostics

July 28, 2009 By MassDevice

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The MassDevice Weekly Roundup brings you the latest medical device news and information.

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First Swine Flu test nod goes to Quest Diagnostics
New Jersey diagnostics maker wins FDA approval for its Focus Diagnostics subsidiary’s H1N1 influenza virus test. Read More more arrow

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Minneapolis devices giant inks settlement deal with one of its arch-rivals in vascular stent patent infringement dispute. Read More more arrow

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Filed Under: Uncategorized Tagged With: Weekly Roundup

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First Swine Flu test nod goes to Quest Diagnostics

July 27, 2009 By MassDevice staff Leave a Comment

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.

Filed Under: Business/Financial News, Diagnostics, Genomics/Molecular Diagnostics Tagged With: Swine Flu

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  • 23andMe co-founder wins bid to take back control of company
  • Neurent Medical opens new manufacturing facility in Ireland
  • Brain Navi wins FDA nod for neurosurgical robot
  • Adona Medical completes enrollment in first-in-human interatrial shunt trial

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