WAUKESHA, WI (June 21, 2007) – Prodesse, Inc. announced today that it will discontinue three of its multiplex ASR products from sale in the US effective August 1, 2007. The products are the underlying supermixes for Hexaplex®, Hexaplex® Plus and ProPneumo-1™, which have been used successfully by laboratory customers for up to eight years. The removal is part of an orderly transition the company is implementing as it migrates its ASR products to in vitro diagnostic (IVD) assays in response to the Food and Drug Administration’s (FDA’s) September 2006 draft guidance document. The company’s ProFlu+™ product for detection of Influenza A, Influenza B and RSV has completed clinical trials and a 510(k) application will shortly be submitted for FDA clearance. The FDA has also received a pre-IDE submission on Prodesse’s Pro hMPV+™ for the detection of human metapneumovirus, while more studies are in the planning stages.
