FDA Clearance Announced for Simplexa C.difficile Molecular Test

Quest Diagnostics has announced that its Simplexa C. difficile Universal Direct Test for use on the 3M™ Integrated Cycler, has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA). The test is intended to aid in the diagnosis of Clostridium difficile – associated disease, one of the most dangerous acquired infections in healthcare settings.

C. difficile-associated disease is a common and sometimes fatal healthcare infection that causes diarrhea and other intestinal problems. It is estimated that as many as 14,000 people die of C.difficile – associated disease in the United States each year, according to the U.S. Centers for Disease Control and Prevention.

The Simplexa 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. This allows for potentially faster results reporting for hospitals and clinical laboratories with results available in approximately one hour.

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 test can be performed on liquid or unformed human stool samples and detects the toxin B gene (tcdB) of C. difficile, including NAP1.