The FDA has cleared the molecular test which is able to detect presence of the toxin within 70 minutes.
GenePOC’s assay for Clostridium difficile (C. diff), GenePOC CDiff, was approved by the US Food and Drug Administration (FDA) today.
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 is approved for use on unformed stool specimens obtained from patients suspected to have C. diff infections.
Traditional infection testing methods used to identify toxigenic C. diff like toxigenic culture and enzyme immunoassays have been found to be labor intensive, to increase delays and have limited sensitivity.
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 the Centers for Disease Control and Prevention (CDC) have identified as an urgent threat in health care settings.
The assay uses GenePoc’s fully automated, real-time (RT) fluorescence-based polymerase chain reaction (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 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 RT-PCR platforms to deliver an accurate diagnosis. The instrument is both CE-marked and FDA-approved.
“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.” Patrice Allibert, chief executive officer, GenePOC, said in a statement.
An earlier version of this article appeared on MD Magazine.