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MDxHealth Prostate Cancer Test Gains New York State Approval

NEW YORK (GenomeWeb) – MDxHealth said today that the New York State Department of Health has approved its SelectMDx test for prostate cancer. The approval completes MDxHealth's state licensing requirements for SelectMDx, allowing the firm to offer the liquid biopsy test in all 50 US states.

SelectMDx is a noninvasive urine-based molecular diagnostic assay to identify patients at increased risk of aggressive prostate cancer. The company hopes the test will help to reduce unnecessary MRI and biopsy procedures in men with signs of a possible prostate cancer.

"This is a major milestone for our SelectMDx reimbursement and commercial strategy," MDxHealth CEO Jan Groen said in a statement. "It will support the growth of our test volumes for SelectMDx in the US, an important market, as well as in other territories."

In July, Palmetto GBA issued a positive final Local Coverage Determination to expand Medicare coverage for the firm's ConfirmMDx test for prostate cancer, an epigenetic assay designed to help prevent repeat biopsies.