MDxHealth SA, a leading molecular diagnostics company in the field of personalized medicine, announced today that its state-of-the-art, 13,448 sq.ft clinical laboratory facility in Irvine, California 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 Dr. 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.”
In the US, the Centers for Medicare and Medicaid Services (CMS) regulate laboratory testing through the Clinical Laboratory Improvement Amendments (CLIA) program to ensure high quality laboratory testing. In total, CLIA covers approximately 200,000 laboratory entities. In contrast to Europe where most testing is performed in hospitals, almost 60-70% of laboratory testing in the US is outsourced to commercial CLIA labs. This constitutes a highly attractive commercial market as one CLIA lab can service the entire US market.
MDxHealth (mdxhealth.com) is a leading molecular diagnostics company that develops and commercializes oncology-based epigenetic testing for personalized medicine. The company’s tests are based on proprietary gene methylation technology and assist physicians with the diagnosis of cancer, prognosis of recurrence risk, and prediction of response to a specific therapy.
For more information:
Mike Sinclair, Halsin Partners
P: +44 20 7318 2955 / E: msinclair[.]halsin.com.
This press release contains forward-looking statements and estimates with respect to the anticipated future performance of MDxHealth and the market in which it operates. Such statements and estimates are based on assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable but may not prove to be correct. Actual events are difficult to predict, may depend upon factors that are beyond the Company’s control, and may turn out to be materially different. MDxHealth expressly disclaims any obligation to update any such forward-looking statements in this release to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based unless required by law or regulation.