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Quest Diagnostics Launches Simplexaâ„¢ C. Difficile Universal Direct Test in Europe

Thu, 05/05/2011 - 6:36am
Bio-Medicine.Org

MADISON, N.J. and CYPRESS, Calif., May 5, 2011 /PRNewswire/ -- Quest Diagnostics Incorporated (NYSE: DGX), the world's leading provider of diagnostic testing, information and services, today announced the availability in Europe of the Simplexa C. difficile Universal Direct test on the 3M™ Integrated Cycler. The new CE marked in vitro diagnostic (IVD) Simplexa test enables fast, high volume lab testing, eliminating the traditional extraction step and allowing for processing of up to 94 patient specimens in about an hour.

Focus Diagnostics, a business of Quest Diagnostics and developer of the Simplexa product line, will unveil the new test as well as the Simplexa Epstein Barr (EBV) and BK Virus tests, which were CE marked last month, during the European Congress of Clinical Microbiology and Infectious Disease Tradeshow, which begins on May 7 in Milan (Exhibit number: 241). A CE mark is a regulatory requirement to sell products in about 35 countries in Europe.

Simplexa tests, running on the 3M™ Integrated Cycler, employ real-time polymerase chain reaction (RT-PCR) to qualitatively and quantitatively detect viruses, bacteria and other agents. The Simplexa C. difficile Universal Direct test is performed on liquid or unformed human stool samples and detects toxin producing strains of Clostridium difficile, including NAP1/B1/027.

"Clostridium difficile is a common cause of antibiotic-associated diarrhea and an extremely important and serious hospital-acquired infection," said Jay M. Lieberman, M.D., medical director for Quest Diagnostics and Focus Diagnostics.  "C. difficile infections (CDI) range in severity from mild diarrhea to life-threatening pseudomembranous colitis, and result in significant suffering and deaths. Timely diagnosis is essential for clinicians when treating patients presenting with possibl

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