Molecular diagnostics company MDxHealth has announced that the New York State Department of Health granted approval for its liquid biopsy SelectMDx test for Prostate Cancer to be used in the state, now making it available to patients and physicians in all 50 states in the U.S.
"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 in a prepared statement. "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 U.S., an important market, as well as in other territories."
SelectMDx is a urine-based molecular diagnostic designed to detect biomarkers that identify those men at higher risk of developing prostate cancer. According to company research published in the journals Urology Practice and the Journal of Urology, the test has the potential to decrease the number of unnecessary tissue biopsies and MRIs for prostate cancer diagnosis by as much as 50% and could potentially save as much as $500 million in annual healthcare costs.
MDxHealth, based in Belgium, transitioned eight years ago from one focused on research and licensing to a developer of diagnostics currently focused on epigenetic markers in urological cancers. The company’s flagship product, ConfirmMDx is a tissue-based test that detects molecular changes in a patient’s tumor that are not detectable via the standard, slide-based tumor evaluation traditionally used by pathologists to diagnose cancer. The company recommends the test for men with a previous negative prostate biopsy, to confirm truly negative men, with the goal of foregoing an unnecessary repeat biopsy.
The company has operated a College of American Pathologists (CAP) accredited lab in Irvine, CA since 2012, and has also been accredited by the Centers for Medicare & Medicaid Services since 2011.