MDxHealth SA, a commercial-stage innovative molecular diagnostics company, announces that Palmetto GBA, a Medicare Administrative Contractor (MAC) that assesses molecular diagnostic technologies under its MolDx program, has issued a draft foundational Local Coverage Determination (LCD) for Biomarkers to Risk-Stratify Patients at Increased Risk for Prostate Cancer. The draft foundational LCD identifies evidence supporting the clinical utility of the SelectMDx® for Prostate Cancer test and, when finalized, would support coverage of the test for qualified Medicare patients throughout the United States.
“We are pleased that Medicare has taken this important step toward providing coverage for SelectMDx — a test that can help improve the disposition of men at risk for aggressive prostate cancer,” stated Michael McGarrity, CEO of MDxHealth. “Medicare coverage, coupled with the recent inclusion of our SelectMDx test in the 2020 National Comprehensive Cancer Network (NCCN) Guidelines for Prostate Cancer Early Detection, further validates the use of SelectMDx to provide clinicians with actionable information, significantly improving the early detection of clinically significant prostate cancer.”
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, follow us on social media at: twitter.com/mdxhealth, facebook.com/mdxhealth and linkedin.com/company/mdxhealth.
The MDxHealth logo, MDxHealth, ConfirmMDx and SelectMDx are trademarks or registered trademarks of MDxHealth SA. All other trademarks and service marks are the property of their respective owners.
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. Successful commercialisation of the Company’s tests depends, in large part, on the availability of coverage and adequate reimbursement from government and private payers. The final determination for Medicare coverage of SelectMDx remains pending following the Company’s submission of an update to its technical assessment under the MolDx program and there can be no assurance that such coverage request will be granted or, if granted, that it will be maintained. 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.