GenePOC has received CE mark for its second bacteriological test CDiff, as well as centripetal sample to result instrument revogene.
The company has 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.
GenePOC is a company that specializes in the development of rapid diagnostic devices which enable the detection and prevention of infectious diseases.
The company has developed the revogene system, enabling rapid microbial testing at the point of care (POC). This instrument can analyze many types of infection within 70 minutes, is easy to operate and deals with a wide range of biological samples, making it a user-friendly and efficient tool.
In 2013, Frost & Sullivan recognized GenePOC by presenting it with the 2013 Best Practices Award North American Molecular Diagnostics Entrepreneurial Company of the Year.