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Preparing for US Market, MDx Health Files for CLIA Certification

NEW YORK (GenomeWeb News) – MDx Health today announced the signing of a lease agreement for a laboratory and office facilities in Irvine, Calif.

As a result, it has filed for CLIA certification for the 13,448-square-feet US site. It also has filed for CLIA certification for its facility in Liege, Belgium.

The company said it expects to launch its first assay for prostate cancer next year. In conjunction with a ramp-up of its commercialization operations, MDx Health also announced it has hired Miriam Reyes as senior director of laboratory operations and Beth Davis as senior director of managed care.

"Establishing a US infrastructure that includes CLIA certification will allow us to penetrate the US market more efficiently and is key to our long-term business strategy," Jan Groen, CEO of MDx Health, said in a statement.

In April, the company raised about $11.7 million, part of which was targeted to set up a CLIA laboratory and create a sales and marketing team in the US.

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