NEW YORK (GenomeWeb) – GenePOC's assay for Clostridium difficile has cleared the US Food and Drug Administration, the Québec-based firm announced today.
Called GenePOC CDiff, the test detects the toxin B gene of toxigenic C. diff strains directly from stool samples within 70 minutes, and is approved for use on unformed stool specimens obtained from patients suspected of having C. diff infection (CDI). It is GenePOC's second test to receive FDA approval following clearance of its Group B Strep test and molecular testing platform earlier this year. The firm's GBS test and platform are also CE marked and are exclusively distributed in the US by Cardinal Health.
The C. diff test uses GenePOC's fully automated, real-time fluorescence-based PCR instrument called Revogene, which functions via a spinning disk format deploying single-use proprietary microfluidic cartridges, or PIEs. The Revogene instrument can be directly connected to the hospital and laboratory information systems for results reporting.
In the US, there are an estimated 293,000 C. diff cases each year, at a cost of $4.8 billion. Traditional testing involves toxigenic culture and enzyme immunoassays, and is labor intensive with limited sensitivity. The sensitivity of molecular testing can increase detection and incidence rates, and the American Society for Microbiology has guided that nucleic acid amplification tests detecting C. diff toxin genes may be used as a stand-alone test.
"A simple one-step algorithm to detect toxigenic C. difficile, using a clinical test with excellent performance, will inevitably contribute to better control the spread of CDI and reduce outbreaks," GenePOC CEO Patrice Allibert said in a statement. "What makes our assay so unique is its right balance between sensitivity and specificity. This translates into the ability to identify patients with CDI from a single GenePOC CDiff test, a molecular test with less than 1 percent unresolved rate according to clinical trial results."