MDxHealth’s clinical laboratory facility in Irvine, California, was awarded CLIA certification by the Centers for Medicare and Medicade. The 13,448 sq. ft. facility is now fully licensed and operational, having also passed California Department of Health inspection.
MDxHealth will use the facility to commercialize epigenetic diagnostic service products for a range of cancer indications, and projects launching its first assay, ConfirmMDx, during the first half of 2012. Further expansion in the U.S. is also planned, the firm states. “Having our CLIA laboratory operational marks the beginning of our commercial activities in the U.S., a key driver to our long-term success,” remarks Jan Groen, Ph.D., CEO. MDxHealth is now well-positioned to introduce its patented epigenetic tests that will aid physicians in the diagnosis and personalized treatment of their patients.”
The molecular diagnostics firm is leveraging its DNA methylation platform to identify and validate biomarkers and develop clinical diagnostic tests for personalized cancer therapy. The platform is also being exploited through collaborations with the pharma industry on companion diagnostics, biomarker discovery, and assays for clinical trials.
MDxHealth is developing three types of clinical diagnostics, primarily for brain, prostate, and lung cancers. ConfirmMDx assays will serve as a cancer diagnostic aid for physicians. InformMDx products will provide prognostic assessment to distinguish between aggressive and non-aggressive tumors. PredictMDx tests are being developed to provide predictive information and help guide treatment decisions for individual patients.