NEWS RELEASE REGULATED INFORMATION INSIDE INFORMATION
IRVINE, CA, and HERSTAL, BELGIUM – February 8, 2017 – MDxHealth SA (Euronext: MDXH.BR) today announced that it has been awarded a US Government Services Administration (GSA) supply contract to use ConfirmMDx for Prostate Cancer within the Department of Veterans Affairs (VA).
The five-year contract, effective February 1, 2017, provides coverage of ConfirmMDx testing at the Medicare rate for veterans within the VA Health System. (V7970-70066 for Federal Supply Schedule 621 II Medical Laboratory Testing and Analysis Services)
According to the VA, prostate cancer is the most frequently diagnosed cancer among veterans with roughly 12,000 new cases annually. Over 600 urologists serve the 152 VA hospitals across the US and it is estimated that more than 200,000 prostate biopsies are performed within the VA healthcare system each year.
“MDxHealth is proud to support the Department of Veterans Affairs with ConfirmMDx testing to help improve patient management and decision-making on the need for prostate biopsies,” stated Dr. Jan Groen, CEO of MDxHealth. “This contract further underscores ConfirmMDx’s clinical value for prostate cancer risk assessment and will be a significant new driver of test volume.”
The U.S. General Services Administration (GSA) leverages the buying power of the federal government to acquire best value for taxpayers and its federal customers. GSA exercises responsible asset management, and delivers superior workplaces, quality acquisition services, and expert business solutions. GSA’s strategic goals are to establish and facilitate stewardship, superior workplaces, best value and innovation. More information about GSA is available at www.gsa.gov.
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 genetic, epigenetic (methylation) and other molecular technologies and assist physicians with the diagnosis of urologic cancers, prognosis of recurrence risk, and prediction of response to a specific therapy. The Company’s European headquarters are in Herstal, Belgium, with laboratory operations in Nijmegen, The Netherlands, and US headquarters and laboratory operations based in Irvine, California. For more information, visit mdxhealth.com and follow us on Twitter at: twitter.com/mdxhealth.
For more information:
Dr. Jan Groen, CEO Jonathan Birt, Chris Welsh, Hendrik Thys (PR & IR)
MDxHealth Consilium Strategic Communications
US: +1 949 812 6979 UK: +44 20 3709 5701
BE: +32 4 364 20 70 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.