Press Release Regulated Information Inside Information August 7, 2020, 7:00 CET
IRVINE, CA and HERSTAL, BELGIUM – August 7, 2020 – MDxHealth SA (Euronext Brussels: MDXH), a commercial-stage innovative molecular diagnostics company, today reports an update and associated delay in obtaining Medicare coverage for its SelectMDx for Prostate Cancer test.
In August 2019, Palmetto GBA, a Medicare Administrative Contractor (MAC) that assesses molecular diagnostic technologies under its Molecular Diagnostic Services (MolDx) program, issued a positive draft local coverage determination (LCD) recommending coverage for the SelectMDx test. Following recent communications with Palmetto GBA related to the retirement of the previously issued draft LCD, the Company has been requested to submit an update to our technical assessment under the MolDx program for Medicare coverage of SelectMDx.
“With the recent inclusion of our SelectMDx test in the National Comprehensive Cancer Network (NCCN) guidelines, it is clear that SelectMDx provides both clinical utility and clinically actionable results to healthcare providers and their patients,” stated Michael McGarrity, CEO of MDxHealth. “We are engaged with the MolDx administrators as well as our clinical advocates and key opinion leaders in prostate cancer. We are confident that this process will ensure that patients continue to have access to the clinical utility clearly established by our SelectMDx test.”
The Company will provide its Mid-Year 2020 Results as scheduled on August 26, 2020.
SelectMDx for Prostate Cancer is a proprietary urine-based, molecular diagnostic test that offers a non-invasive liquid biopsy method to assess a patient’s risk for prostate cancer. SelectMDx helps identify men at increased risk of harboring aggressive, potentially lethal, prostate cancer who may benefit most from a prostate biopsy and earlier detection. The test delivers a negative predictive value (NPV) of 95% for clinically significant disease, helping to reduce the need for MRI procedures and invasive prostate biopsies by up to 50%, thereby reducing healthcare costs. The test has been included in the National Comprehensive Cancer Network (NCCN) and European Association of Urology (EAU) clinical guidelines.
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 social media at: twitter.com/mdxhealth, facebook.com/mdxhealth and linkedin.com/company/mdxhealth.
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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.