OREANDA-NEWS. MDxHealth SA (Euronext: MDXH.BR) announced that Independence Blue Cross (Independence) has issued a positive medical coverage policy decision for the ConfirmMDx® for Prostate Cancer test.

Independence Blue Cross is the leading health insurance organization in southeastern Pennsylvania. With its affiliates, Independence serves nearly 8.5 million people in 32 states and the District of Columbia, including more than 2.5 million in the region.

Independence is one of the 38 independent companies that form the Blue Cross and Blue Shield Association (BCBSA) that collectively cover more than 98 million people or 1 in 3 Americans. This positive policy decision for their commercial and Medicare lives represents the first BCBSA plan to establish coverage for ConfirmMDx for Prostate Cancer.

"This positive coverage decision by Independence Blue Cross is a significant milestone as we work towards achieving nationwide payer adoption of our ConfirmMDx for Prostate Cancer test," stated Dr. Jan Groen, CEO of MDxHealth. "This decision demonstrates that our investment in clinical studies and our work with managed care organisations in the US continues to yield positive results."

ConfirmMDx for Prostate Cancer is the first epigenetic, and only tissue-based test in the 2016 NCCN Guidelines for early detection of prostate cancer which addresses false negative biopsy concerns. It is the only molecular diagnostic test that provides a very high negative predictive value (NPV) of 96% for clinically significant prostate cancers, and 90% NPV for all prostate cancers, as well as prostate mapping of the test results to help guide repeat biopsies. Each year, more than 1 million American men undergo an invasive prostate biopsy with a negative result, however approximately 30% of those men actually have prostate cancer. The current standard of care for prostate biopsy procedures samples less than 1% of the prostate, leaving men at risk for undetected cancer and leading to a high rate of repeat biopsies, even on cancer-free men. ConfirmMDx for Prostate Cancer helps urologists identify low-risk men who may forego an unnecessary repeat biopsy and high-risk men who may benefit from intervention. To date more than 3,000 urologists have ordered ConfirmMDx on more than 45,000 patients. ConfirmMDx has qualified for Medicare reimbursement and covered by numerous private health insurance plans.