IRVINE, CA, and HERSTAL, BELGIUM - October 31, 2016 - MDxHealth SA (Euronext: MDXH.BR), today announced that its ConfirmMDx ® for Prostate Cancer test has been granted a Category I MAAA Current Procedural Terminology (CPT) code by the American Medical Association (AMA).
"Obtaining Category I CPT code for ConfirmMDx is an important reimbursement milestone that can only be achieved once there is sufficient evidence demonstrating the test improves patient outcomes, has the support of the specialty medical associations, inclusion in medical guidelines and widespread physician adoption," stated Dr. Jan Groen, CEO of MDxHealth. "We believe that ConfirmMDx has become a 'standard of care" for the management of men with a with a previous negative prostate biopsy and that this Category I designation will facilitate negotiations with payors and most importantly, timely reimbursement."
CPT Category codes are granted and regulated by the AMA CPT Editorial panel and are widely used by government payors and insurance companies to describe health care services and procedures for reimbursement purposes. The unique ConfirmMDx CPT code, effective in January 2018, will streamline reimbursement from US government programs such as Medicare and Medicaid and commercial health insurance companies. Criteria for the Category I MAAA designation include literary documentation of clinical efficacy and consistency with current medical practice as well as widespread adoption and use across the US and with a frequency consistent with intended clinical use.
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. ConfirmMDx has qualified for Medicare reimbursement and covered by numerous private health insurance plans.
MDxHealth is a multinational healthcare company that provides actionable molecular diagnostic information to personalize the diagnosis and treatment of cancer. The company's tests are based on proprietary gene methylation (epigenetic) and other molecular technologies 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 .
For more information:
Dr. Jan Groen, CEO
US: +1 949 812 6979
BE: +32 4 364 20 70
Jonathan Birt, Chris Welsh, Hendrik Thys, Cameron Standage (PR & IR)
Consilium Strategic Communications
UK: +44 20 3709 5701
US: +1 917 322 2571 (Rx Communications Group LLC)
This press release contains forward-looking statements and estimates with respect to the anticipated future performance of MDxHealth and the market in which it operates. Such statements and estimates are based on assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable but may not prove to be correct. Actual events are difficult to predict, may depend upon factors that are beyond the company's control, and may turn out to be materially different. MDxHealth expressly disclaims any obligation to update any such forward-looking statements in this release to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based unless required by law or regulation. This press release does not constitute an offer or invitation for the sale or purchase of securities or assets of MDxHealth in any jurisdiction. No securities of MDxHealth may be offered or sold within the United States without registration under the U.S. Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable U.S. securities laws.
NOTE: The MDxHealth logo, MDxHealth, ConfirmMDx, SelectMDx, AssureMDx and PredictMDx are trademarks or registered trademarks of MDxHealth SA. All other trademarks and service marks are the property of their respective owners.