FDA Clears the Quest Diagnostics Simplexa C. difficile Molecular Test

Quest Diagnostics (NYSE: DGX) today announced that the U.S. Food and Drug Administration (FDA) 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, one of the most common and dangerous acquired infections in healthcare settings. 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.