For Immediate Release
Prodesse to Discontinue 3 Multiplex ASR’s from Sale in US
Company also has submitted a pre-IDE for clinical trials
for human metapneumovirus
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products to in vitro diagnostic (IVD) assays in response to the Food and Drug Administration’s (FDA’s) September 2006 draft guidance document.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.
Prodesse CEO Tom Shannon commented, “Though the actual ASR regulations have not changed, the September 2006 ASR draft guidance documents clearly show that the FDA’s posture towards ASRs has changed. Our company prefers to clear up any ambiguity in our customers minds by moving from ASRs to IVDs.”
All other company products, including research use only and CE marked products, will not be affected by this announcement. Prodesse has informed all affected customers of the August implementation date.
About Prodesse
Prodesse is a biotechnology company focused on developing molecular diagnostic reagents for a variety of infectious disease applications. The company’s products are designed based on a combination of Prodesse’s patented technologies and other licensed technologies. Prodesse sells research use only kits worldwide, CE Marked in vitro diagnostic kits outside the US , FDA 510(k) cleared products worldwide and analyte specific reagents in the US . Analyte specific reagents can be used by CLIA certified laboratories to develop assays for detecting infectious organisms. The company’s products can be used on multiple nucleic acid extraction and PCR detection platforms. Prodesse also operates a CLIA certified laboratory for testing services in the Midwest area. For more information about Prodesse and its products, call 888-589-6974 or go to www.prodesse.com.
Press Contact:
Andy Shrago, Chief Marketing Officer
Prodesse, Inc.
Phone: (262) 446-0700
Email: ashrago@prodesse.com