Epigenetic molecular diagnostic is designed to identify patients who won’t need repeat biopsies.
Plus Diagnostics is to co-market MDxHealth’s ConfirmMDx™ prostate cancer test in the U.S. Plus is a U.S. anatomic pathology lab offering a range of multispecialty services. It will co-promote the assay through its national network of urologists.
“The national reach afforded by Plus Diagnostics provides a direct channel into the urology community and will aid in meeting the growing demand for our test,” comments Jan Groen, MDxHealth CEO. ConfirmMDx will be carried out at the firm’s laboratory at Irvine, CA, which achieved CLIA certification by the Centers for Medicare and Medicade in January.
ConfirmMDx for prostate cancer is a laboratory-developed epigenetic test designed to help identify cancer in men who have undergone a biopsy procedure and are shown to have an elevated PSA level, abnormal DRE, or BPH. The assay effectively represents a tool for assessing the presence or absence of cancer cells in biopsy tissue and identifies which patients won’t need to undergo unnecessary repeat biopsies or excessive screening procedures.
The firm says the test can detect a validated epigenetic field effect associated with the cancerization process at the DNA level in cells adjacent to cancer foci. This molecular halo around the cancer lesion may not necessarily be detectable under the microscope.