MDxHealth announces approval for SelectMDx for prostate cancer by New York State

MDxHealth SA (Euronext: MDXH.BR) announced that the New York State Department of Health has approved its SelectMDx test for Prostate Cancer. This completes MDxHealth's state licensing requirements for SelectMDx, allowing the Company to offer the liquid biopsy test in all 50 states across the US.

SelectMDx is a proprietary, non-invasive urine-based molecular diagnostic test to identify men at increased risk of harboring aggressive prostate cancer, who may benefit most from earlier detection. Studies have shown that the test can reduce the need for unnecessary invasive biopsies and MRI procedures by up to 50%. A prospective clincal utility study recently published in the journal Urology Practice clearly demonstrated the value of SelectMDx in guiding urologists with their initial prostate biopsy decision-making. Similarly, a US based study published in the Journal of Urology assessing the cost-effectiveness of SelectMDx projected potential annual healthcare cost savings of over $500 million.  

"We're thrilled to receive this approval from New York State which means SelectMDx will now be widely available to all physicians and their patients throughout the United States," said Dr. Jan Groen, MDxHealth's CEO. "This is a major milestone for our SelectMDx reimbursement and commercial strategy. It will support the growth of our test volumes for SelectMDx in the US, an important market, as well as in other territories."

The New York State Department of Health's Clinical Laboratory Evaluation Program (CLEP) regulates and oversees clinical diagnostic laboratories that test specimens from New York State residents, including Laboratory Developed Tests (LDTs). The CLEP seeks to ensure the accuracy and reliability of test results in clinical laboratories located in, or accepting specimens from, New York State residents. It is widely regarded as one of the most rigorous review processes due to its stringent quality standards.

The MDxHealth laboratory has been accredited by the College of American Pathologists (CAP) since 2012, and the Centers for Medicare and Medicaid Services (CLIA) since 2011. In addition, the laboratory is licensed by the California Department of Public Health, Pennsylvania State Department of Health, State of Rhode Island Department of Health and Maryland Department of Health.

Source: MDxHealth

MDxHealth announces approval for SelectMDx for prostate cancer by New York State

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