IRVINE, CA, and HERSTAL, BELGIUM - March 2, 2016 - MDxHealth SA (Euronext: MDXH.BR), today 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. The new guidelines are published online at www.nccn.org.
"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."
About ConfirmMDx® for Prostate Cancer
ConfirmMDx for Prostate Cancer helps urologists identify men who may forego an unnecessary repeat biopsy. 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.
About MDxHealth®
MDxHealth is a multinational healthcare company that provides actionable epigenetic and molecular information to personalize the diagnosis and treatment of cancer. The company's tests are based on proprietary DNA methylation (epigenetic) technology and assist physicians with the diagnosis of cancer, prognosis of recurrence risk, and prediction of response to a specific therapy. For more information visit mdxhealth.com and follow us on Twitter at: twitter.com/mdxhealth.
Dr. Jan Groen, CEO
MDxHealth
US: +1 949 812 6979
BE: +32 4 364 20 70
info@mdxhealth.com
Amber Fennell, Chris Welsh, Hendrik Thys (PR & IR)
Consilium Strategic Communications
UK: +44 20 3709 5701
Cell: + 44 7739658783
mdxhealth@consilium-comms.com
"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."
About ConfirmMDx® for Prostate Cancer
ConfirmMDx for Prostate Cancer helps urologists identify men who may forego an unnecessary repeat biopsy. 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.
About MDxHealth®
MDxHealth is a multinational healthcare company that provides actionable epigenetic and molecular information to personalize the diagnosis and treatment of cancer. The company's tests are based on proprietary DNA methylation (epigenetic) technology and assist physicians with the diagnosis of cancer, prognosis of recurrence risk, and prediction of response to a specific therapy. For more information visit mdxhealth.com and follow us on Twitter at: twitter.com/mdxhealth.
Dr. Jan Groen, CEO
MDxHealth
US: +1 949 812 6979
BE: +32 4 364 20 70
info@mdxhealth.com
Amber Fennell, Chris Welsh, Hendrik Thys (PR & IR)
Consilium Strategic Communications
UK: +44 20 3709 5701
Cell: + 44 7739658783
mdxhealth@consilium-comms.com
