Today, Applied BioCode announced that they have completed their beta site trials for the BioCode MDx 3000 and their 18-Plex Gastrointestinal Pathogen Panel. The beta site trials were held at both the University of California, Los Angeles, and at the Poplar Healthcare Laboratory in Memphis, TN, and were completed during January and February this year. Applied BioCode have begun shipping systems to their clinical evaluation sites in March. “Completing the beta site trials is an exciting milestone for Applied BioCode,” stated Winston Ho, President of Applied BioCode. “We have tested our new investigational molecular diagnostics system in clinical laboratories and have gotten excellent feedback on the diagnostic utility of the BioCode MDx 3000 system.”
At Poplar Healthcare, Anami Patel, Ph.D., Vice President of Genomics Operations and Development, was in charge of the Beta Site Trial. He stated: “The BioCode MDx 3000 performed very well in our laboratory. Once we were trained on the BioCode MDx 3000 system we found it very easy to operate. We expect the BioCode MDx 3000 system to provide a workflow advantage for our laboratory and will be an ideal solution for high volume, highly multiplex molecular diagnostic testing.”
At the UCLA Health System, Romney Humphries, Ph.D., Section Chief of Clinical Microbiology and Assistant Professor, stated, “We completed the beta testing on the BioCode MDx 3000 system and it went well.”
Winston Ho also said that he expects that the clinical evaluations from five sites will be concluded by June with submission to the FDA in the subsequent months. FDA 510k clearance is possible in the 4th quarter of 2017.