FDA Approves GenePOC C. Diff Test

The US Food and Drug Administration has approved GenePOC’s assay, GenePOC CDiff, for Clostridium difficile (C. Diff).

The qualitative in-vitro diagnostic test, GenePOC CDiff, detects the toxin B gene of toxigenic C. diff strains directly from stool samples within 70 minutes. It’s approved for use on unformed stool specimens obtained from patients suspected to have C. diff infections.

“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 C. diff infections and reduce outbreaks” Patrice Allibert, chief executive officer, GenePOC, 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 C. diff infections from a single GenePOC CDiff test, a molecular test with less than 1% unresolved rate according to clinical trial results.”

The test provides a novel and highly flexible alternative to assist clinicians in rapidly identifying, isolating and treating patients with C. diff. Consequently, rapid management of patients with the infection will aid in preventing the spread of the bacteria, which is identified as an urgent threat in healthcare settings by the Centers for Disease Control (CDC).

The assay uses GenePoc’s fully automated, real-time fluorescence-based PCR instrument, Revogene, which functions via a spinning disk format and deploys single-use proprietary microfluidic cartridges. The instrument can directly connect to the hospital and laboratory information systems for results reporting and can be used to process from 1 up to 8 samples simultaneously in the same run.

Revogene is an automated and stand-alone instrument that enables testing of single-use proprietary microfluidic cartridges, or PIEs, with fluorescence-based real-time polymerase chain reaction platforms to deliver an accurate diagnosis. The instrument is both CE-marked and FDA approved.

Traditional infection testing methods used to identify toxigenic C. difficile like toxigenic culture and enzyme immunoassays have been found to be labor intensive, to increase delays and have limited sensitivity.

A press release was made available.

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