MDxHealth’s 13,448-square-foot clinical laboratory facility in Irvine, Calif, has received Clinical Laboratory Improvements Amendments (CLIA) certification of registration from the Centers for Medicare and Medicaid Services (CMS). In addition, MDxHealth’s laboratory has passed inspection by the California Department of Health and is now fully licensed and operational.
Through its CLIA-certified laboratory, MDxHealth will commercialize proprietary epigenetic diagnostic service products for a number of cancer indications. The company expects to launch its first assay, Prostate ConfirmMDx™, in the first half of 2012.
“Having our CLIA laboratory operational marks the beginning of our commercial activities in the US, a key driver to our long-term success. The demand for molecular testing in cancer is growing rapidly. MDxHealth is now well positioned to introduce its patented epigenetic tests which will aid physicians in the diagnosis and personalized treatment of their patients,” said Jan Groen, CEO of MDxHealth. “We have completed the laboratory construction and passed the state inspection in record time, demonstrating the dedication and proficiency of our operations team in Irvine. MDxHealth is building a world class scientific and commercial team in the US and plans further expansion in the months ahead.”