Quest Simplexa C difficile molecular test wins FDA nod

The US Food and Drug Administration (FDA) has cleared Quest Diagnostics' Simplexa C difficile universal direct test on the 3M integrated cycler.

Simplexa direct test includes a real-time polymerase chain reaction which uses liquid or unformed human stool samples to detect the toxin B gene (tcdB), NAP1 gene of C difficile.

The test uses a proprietary technique to eliminate nucleic-acid extraction and completes the entire testing process in about an hour.

Quest Diagnostics and Focus Diagnostics infectious disease medical director Jay Lieberman said PCR tests which are specific and sensitive in the detection of the tcdB gene of C difficile, are essential for identifying and treating the infection as well as containing its spread.