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MDxHealth US laboratory facility wins CMS CLIA certification

Lisa Mathew Published 23 January 2012

The Centers for Medicare and Medicaid Services (CMS) has granted Clinical Laboratory Improvements Amendments (CLIA) certification to MDxHealth's 13,448 ft² clinical laboratory facility in Irvine, California, US.

The company will market its proprietary epigenetic diagnostic service products for a number of cancer indications, through its CLIA -certified laboratory.

MDxHealth's laboratory has also passed inspection by the California Department of Health, and is now fully licensed and operational.

MDxHealth CEO Jan Groen said the company is now well-positioned to launch its patented epigenetic tests which will aid physicians in the diagnosis and personalized treatment of their patients.

The company expects to introduce its Prostate ConfirmMDx assay, in the first half of 2012.

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