The FDA has granted 510(k) clearance to Quest Diagnostics Simplexa C. difficile Universal Direct Test on the 3M™ Integrated Cycler. The test, from the company's Focus Diagnostics business, 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, without the need for nucleic-acid extraction.

Using the Simplexa test, hospital and other labs may complete the entire testing process in about an hour.

With the FDA clearance, 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.