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GenePOC Instrument, Assays Get CE Mark

NEW YORK (GenomeWeb) – GenePOC today announced it has received CE marking for its Revogene instrument and tests for Group B Streptococcus and Clostridium difficile for marketing in Europe and other geographies that recognize the designation.

The Quebec City-based rapid molecular devices firm, which is part of Debiopharm, added that it has completed clinical trials for GBS for the US Food and Drug Administration and expects to start clinical trials for C. difficile by mid-January.

GenePOC said in September that Debiopharm invested "tens of millions of dollars" into the firm to accelerate the development of its molecular diagnostic platforms and infectious disease assays with an eye toward pairing the tests with Debiopharm's drug offerings.

GenePOC's PCR-based platform was originally developed at the Centre de Recherche en Infectiologie at the University of Laval in Quebec City, and uses spinning disc technology to perform fully automated, real-time PCR on cartridges in under one hour.