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FDA clears new C. difficile test
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GenePOC Inc. has announced the launch and FDA clearance of its Clostridium difficile molecular test, GenePOC CDiff, in the United States.
The test, for use on the revogene instrument, targets the toxin B gene of toxigenic C. difficile strains in unformed stool specimens obtained from patients suspected of having C. difficile infection (CDI), according to a press release.
The GenePOC CDiff assay will allow health care professionals to identify the presence of toxigenic C. difficile within 70 minutes of loading the patient sample in the test cartridge or proprietary microfluidic cartridges.
Traditional testing detection methods for toxigenic C. difficile, like toxigenic culture and enzyme immunoassays (EIA), can be hard to use and have limited sensitivity, according to the release. The test provides clinicians with an easier alternative to rapidly identify, isolate and treat patients with CDI, and help prevent the spread of the threatening bacteria, per the release.
“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” Patrice Allibert, PhD, CEO of GenePOC, said in the release. “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% unresolved rate according to clinical trial results. Our test is performed on the affordable, user-friendly revogene instrument, which can be directly connected to the hospital and laboratory information systems for seamless transmission and communication of actionable results.”
Disclosures: Allibert is CEO of GenePOC Inc.