Synbiotics has announced that it is seeking 510(k) authorization from the FDA for the use of its FluDetect avian influenza virus rapid test strip in humans.
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This represents Synbiotics first foray into the human point-of-care diagnostic marketplace. While it is not Synbiotics’s initial intent to market this product itself to the human field, it is actively seeking an established strategic human diagnostic partner, to market, sell and distribute this product.
Currently, the FluDetect product is said to be the only USDA approved rapid point of care test for avian influenza in the veterinary field. FluDetect has been heralded for its extreme sensitivity in a simple to use test format that requires no equipment, nor extensive training to perform. Management believes that this may be the first crossover test to be licensed for use both in humans and animals and can be a vital tool to healthcare institutions for both seasonal flu testing as well as in endemic situations.
Paul Hays, president & CEO of Synbiotics, said: “It is our goal to find a partner in a timely fashion to be prepared to enter the human market for the 2008-2009 flu season.”
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