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FDA Grants Clearance To Quest Diagnostics' Simplexa C. Difficile Molecular Test

Quest Diagnostics (DGX) announced that the U.S. Food and Drug Administration has granted 510(k) clearance to its Simplexa C. difficile Universal Direct Test on the 3M Integrated Cycler.

The test, from the company's Focus Diagnostics business, is intended to aid in the diagnosis of Clostridium difficile-associated disease. It uses a proprietary technique to eliminate the time consuming nucleic-acid sample extraction process required by many other molecular tests, for potentially faster results reporting for hospitals and clinical laboratories.

Simplexa tests, running on the 3M Integrated Cycler, employ real-time polymerase chain reaction (RT-PCR) to qualitatively detect viruses, bacteria and other analytes. The Simplexa C. difficile Universal Direct test is performed on liquid or unformed human stool samples and detects the toxin B gene (tcdB) of C. difficile, including NAP1.

C. difficile-associated disease is a common and sometimes fatal healthcare-associated infection that causes diarrhea and other intestinal problems.

The company said that the Simplexa C. difficile Universal Direct Test on the 3M Integrated Cycler is immediately available in the United States. Focus Diagnostics launched the test in Europe during the second quarter of 2011.

by RTT Staff Writer

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