GenePOC to Announce CE Marking of Its Revogene™ Instrument and Its Second Test, CDiff

GenePOC, Inc., a member of Debiopharm Group, announced a new phase in its operations after obtaining CE marking for its revogene instrument and its first set of tests for Group B Streptococcus (GBS) and C. difficile. With this in place in addition to the European distributor network announced in November 2016, GenePOC is preparing for commercialization in Europe and other countries accepting CE mark for clinical diagnostics. The GenePOC team is proud to have reached this critical milestone.

"GenePOC has achieved another very important milestone for its future. By successfully combining the CE mark for the revogene instrument with 2 critical tests, GBS and CDiff, using complex clinical specimens and by obtaining very good clinical performance versus the reference methodology, GenePOC shows its ability to build a menu for infectious diseases, including Hospital Acquired Infections. This step, in line with our engagement, is only the first of a long series that will allow us to become a key actor in diagnosis at the point of service - and more precisely as close as possible to the patient," added Patrice Allibert CEO of GenePOC.

Further to the CE marking, clinical trials for the FDA on GBS have been completed and GenePOC expects the start of its CDiff clinical trial by mid-January.