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Dx Focus May 5, 2011: Clinical and Regulatory PCR and Nucleic Acid Testing News


Quest Diagnostics has secured CE Marking for its Simplexa C. difficile Universal Direct test and has launched it in Europe.

The test, marketed by the company's Focus Diagnostics division and developed for the 3M Integrated Cycler, can process up to 94 patient specimens in about an hour, Quest said.

The company last week gained CE Marking for its Simplexa tests for Epstein-Barr virus and BK virus (PCR Insider 4/28/2011).

Quest said it will launch all three new tests during the European Congress of Clinical Microbiology and Infectious Disease Tradeshow, which begins on May 7 in Milan.

The Simplexa C. difficile test is performed on liquid or unformed human stool samples and detects toxin-producing strains of Clostridium difficile, including NAP1/B1/027.

The company said that C. difficile infections are estimated to be responsible for 1.1 in 1,000 hospital admissions in Europe and this frequency is expected to double over the next four decades.

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