IRVINE, California, and HERSTAL, BELGIUM – June 20, 2014 – MDxHealth SA (NYSE Euronext: MDXH), today announced that a draft coverage policy (Local Coverage Determination or LCD) for the ConfirmMDx® for Prostate Cancer test has posted on the Centers for Medicare and Medicaid Services (CMS) website.
Under Medicare policies, the posting of a draft LCD indicates commencement of a 45-day public comment period. Once comments are reviewed and a final LCD is released, the final LCD goes into effect following a 45-day notification period.
“MDxHealth appreciates the opportunity to have worked with Palmetto GBA®, the Medicare Administrative Contractor that establishes coverage policies for testing billed by our laboratory for Medicare beneficiaries, to reach this important milestone. We are pleased with Palmetto GBA’s draft coverage determination with data development requirements for the ConfirmMDx test,” stated Dr. Jan Groen, CEO of MDxHealth.
Over 975,000 American men receive a negative prostate biopsy result each year, though approximately 25% of these men may still harbor occult prostate cancer. This well-documented risk of undetected cancer, often with clinically significant Gleason scores, leads to a high rate of repeat biopsies with greater than 40% of men receiving at least one repeat biopsy, and many receiving a 3rd and 4th biopsy. Today’s gold standard diagnostic approach is the prostate biopsy procedure, collecting 10-12 needle core biopsy samples; however this sampling represents less than 1% of a man’s prostate. ConfirmMDx for Prostate Cancer is an epigenetic assay to help urologists distinguish patients who have a true-negative biopsy from those at risk for undetected cancer. The test is able to detect an epigenetic field effect or “halo” associated with the cancerization process at the DNA level. This molecular “halo” around a cancer lesion can be present despite having a normal appearance under the microscope. The test helps urologists rule out prostate cancer-free men from undergoing unnecessary repeat biopsies and rule in high-risk patients who may require repeat biopsies and potential treatment. Performance of the proprietary ConfirmMDx genes and technology has been published in 42 studies with over 4,100 patients tested.
MDxHealth is a leading molecular diagnostic company that develops and commercializes epigenetic tests to support cancer treatment. The company’s tests are based on proprietary gene methylation (epigenetics) 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.
For more information:
|Dr. Jan Groen, CEO
|Mike Sinclair (media)
|Len Hall (investors)
|Allen & Caron, Inc
|US: +1 949 812 6979
|UK: +44 20 7318 2955
|US: +1 949 474 4300
|BE: +32 4 364 20 70
|Cell:+44 7968 022075
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 and PredictMDx are trademarks or registered trademarks of MDxHealth SA. All other trademarks and service marks are the property of their respective owners.