Prodesse develops molecular diagnostic reagents for a variety of infectious disease applications. Prodesse sells three FDA 510(k) cleared products in the United States, and two additional CE-marked products in Europe. The company's products can be used in conjunction with various nucleic acid extraction and real-time PCR (polymerase chain reaction) platforms, including Cepheid's SmartCycler(®) II System.
Prodesse's ProFlu+(TM) test was cleared by the U.S. Food and Drug Administration (FDA) in January 2008 for the detection and discrimination of Influenza A Virus, Influenza B Virus and Respiratory Syncytial Virus. It is the only commercially available, FDA-cleared molecular test for these respiratory viruses that uses real-time PCR technology. Test results can be obtained in as little as three hours using the assay - a significant improvement over culture-based methods. During a public health emergency, this speed to result and the high sensitivity of molecular tests can make important contributions to effective infection control efforts.
Prodesse also sells FDA-approved, real-time PCR assays for the clinical diagnosis of Clostridium difficile (C. diff), a bacteria that is the most serious cause of antibiotic-associated diarrhea, and human metapneumovirus, a common cause of lower respiratory infection in children.
Gen-Probe expects to finance the transaction with cash currently on its balance sheet.
Gen-Probe expects to record, under U.S. GAAP, charges for non-recurring cash and non-cash acquisition-related costs following the close of the transaction. The magnitude of these charges will not be determined, under the rules of purchase accounting, until an independent, third party valuation has been completed to allocate the purchase price over the assets and liabilit
|SOURCE Gen-Probe Incorporated|
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