MDxHealth SA has announced that its ConfirmMDx® for Prostate Cancer test has been included in the United States' 2016 National Comprehensive Cancer Network (NCCN) Guidelines. The NCCN is an alliance of 23 world-leading cancer centers from across the US. The guidelines provide recommendations to ensure that patients receive diagnostic testing services and treatment that have been shown to improve clinical outcomes.
"We are delighted that the NCCN panel for early detection of prostate cancer included our ConfirmMDx test into these highly respected clinical guidelines. Inclusion in the guidelines establishes ConfirmMDx as a 'standard of care' for the management of men at risk for undetected prostate cancer," stated Dr. Jan Groen, Chief Executive Officer of MDxHealth.
"This is the second MDxHealth test to be included in the NCCN guidelines, with PredictMDx for Glioblastoma added in 2013, and illustrates our commitment to delivering clinically valuable solutions to improve patient outcomes."
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 high negative predictive value (NPV) of 90% for all prostate cancers, and a NPV of 96% for clinically significant prostate cancers, as well as prostate mapping of the test results to help guide repeat biopsies.
To date nearly 2,800 urologists have ordered ConfirmMDx on more than 40,000 patients. ConfirmMDx has qualified for Medicare reimbursement and is also available to more than 152 million insured lives via private health insurance plans.
"Gaining acceptance into the NCCN Guidelines has been at the core of our medical affairs strategy, and supported by our investment in building a strong dossier of clinical evidence," commented Christopher Thibodeau, Chief Commercial Officer of MDxHealth. "This is a major milestone for the Company which paves the way for widespread adoption of the assay within the US urology community, and as importantly, strengthens our position to negotiate with health insurance plans."