NEW YORK (GenomeWeb News) – MDxHealth today said that it has received CLIA certification for its laboratory in Irvine, Calif.
The Liege, Belgium-based firm also said that the lab has passed inspection by the California Department of Health and is now fully licensed and operational.
MDxHealth plans to offer epigenetic diagnostic products for a number of cancer indications. Its first assay, Prostate ConfirmMDx will be launched in the first half of this year, it said.
"Having our CLIA laboratory operational marks the beginning of our commercial activities in the US, a key driver to our long-term success," MDxHealth CEO Jan Groen said in a statement. "MDxHealth is now well-positioned to introduce its patented epigenetic tests which will aid physicians in the diagnosis and personalized treatment of their patients."