The Food & Drug Administration granted an emergency use authorization for a rapid Swine Flu test for troops serving overseas.
The authorization, which permits the use of unapproved medical products during times of emergency, will allow the U.S. Department of Defense to distribute the test to its laboratories to quickly determine if there are outbreaks of the H1N1 influenza strain in service members.
The test, called the CDC swH1N1 (swine) Influenza Real-Time RT-PCR, was developed by the Centers for Disease Control, according to FDA spokeswoman Mary Long. Calls to the CDC seeking comment on any business partners the federal agency may have used in developing the test were not immediately returned.
That news might have been 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 of which were jockeying for position in the race to get a rapid Swine Flu diagnostic to market.
For a time, it appeared that Inverness was a leader in the race, especially during the initial phases of the outbreak.
But as recently as Aug. 19, Inverness said it was unable to to conclusively prove that its BinaxNOW test could distinguish between the seasonal influenza A virus and Swine Flu.
The BinaxNow test’s “ability to detect human infection with the 2009 H1N1 influenza virus in clinical specimens is unknown,” according to a company press release.
There have been 7,963 hospitalizations and 522 deaths as a result of the new strain, according to an Aug. 21 CDC press briefing.