KANSAS CITY, Mo., March 13 /PRNewswire/ -- Synbiotics Corporation today announced that it is seeking 510(k) authorization from the Food & Drug Administration (FDA) for the use of its FluDetect(R) Avian Influenza Virus rapid test strip in humans. This represents Synbiotics first foray into the human point-of-care diagnostic marketplace. While it is not Synbiotics’ 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(R) product is the only USDA approved rapid point of care test for avian influenza in the veterinary field. FluDetect(R) 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 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.
“The feedback we have received on the outstanding field performance of FluDetect(R) in avian influenza has encouraged us to seek human use,” said Paul Hays, Synbiotics’ President & Chief Executive Officer. “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,” said Hays. Inquiries by potential partners should be made to Ronan Molloy at ronanm@synbiotics.com.
Synbiotics Corporation develops, manufactures and markets veterinary diagnostic products for the poultry, livestock and companion animal markets worldwide. Synbiotics is an expert in avian influenza surveillance and early detection. Synbiotics manufactures and distributes its products through its operations in San Diego, California, and Lyon, France. For information on Synbiotics and its products, visit the Company’s website at http://www.synbiotics.com.
Contacts: Paul Hays
CONTACT: Paul Hays of Synbiotics Corporation, +1-816-464-3502
Web site: http://www.synbiotics.com/
