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GenePOC C. Diff MDx Approved in Canada

NEW YORK (GenomeWeb) – GenePOC said today that it has launched its assay to detect Clostridium difficile infection (CDI) in Canada after the test received approval from the Canadian government.  

The GenePOC CDiff test is a qualitative qPCR-based molecular diagnostic assay to detect the toxin B gene of toxigenic C. diff in stool specimens from patients suspected of having CDI. The test runs on Revogene, an automated, stand-alone instrument that enables testing in single-use proprietary microfluidic cartridges called PIEs with fluorescence-based detection. It takes approximately 70 minutes to run, Québec City-based GenePOC said.

"The approval of our CDiff assay by Health Canada for the diagnostic of toxigenic C. difficile is in line with the objectives of control and prevention of this nosocomial infection," GenePOC CEO Patrice Allibert said in a statement. "Our molecular tests have been demonstrated to provide specific, sensitive, and timely identification of patients with toxigenic CDI ... [and] they are easy to use and affordable."

CDI is the main cause of infectious diarrhea in hospitals and long-term care facilities in Canada, results in significant mortality, and is associated with 260 million dollars in health care costs. A 2016 study at a Québec hospital suggested that using molecular C. diff testing to screen all hospitalized patients, followed by partially isolating carriers of the bacteria, prevented about 60 percent of expected infections and reduced costs by avoiding expensive treatments.

GenePOC CDiff was CE marked and launched in Europe last year following additional investment from Debiopharm Group, a global biopharmaceutical group that includes five companies in the life science space, and of which GenePOC is a member. The test has also been cleared by the US Food and Drug Administration, as has the firm's Group B Strep test.