NEWS RELEASE – REGULATED INFORMATION
May 19, 2022, 4:00PM EDT / 22:00 CET
Palmetto GBA’s MolDX Issues Foundational LCD Covering the Indication for SelectMDx® for Prostate Cancer
IRVINE, CA, and HERSTAL, BELGIUM – May 19, 2022 – – MDxHealth SA (NASDAQ/Euronext: MDXH), a commercial stage precision diagnostics company, announces that Palmetto GBA, a Medicare Administrative Contractor (MAC) that assesses molecular diagnostic technologies under its MolDX program, has finalized a foundational Local Coverage Determination (LCD) for Molecular Biomarkers to Risk-Stratify Patients at Increased Risk for Prostate Cancer that covers the indication for our SelectMDx® for Prostate Cancer test. The foundational LCD identifies evidence supporting the clinical utility of our SelectMDx test and, when the LCD becomes effective on July 3, 2022, is expected to support coverage of our test for qualified Medicare patients throughout the United States.
Michael McGarrity, CEO of MDxHealth, commented: “We are pleased to report this very positive and important development for MDxHealth. We are certain that our clinical data for the SelectMDx test, adoption from our urology customer base and inclusion in the NCCN Guidelines merits coverage by Medicare. We look forward to continuing to advance availability of our test to current and new customers and patients entering the diagnostic pathway of prostate cancer. Our SelectMDx test, coupled with our ConfirmMDx® test post initial biopsy, presents a clinically actionable pathway for urologists and patients.”
The foundational LCD can be found here.
MDxHealth is a commercial-stage precision diagnostics 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 and prognosis of recurrence risk. The Company’s European headquarters are in Herstal, Belgium, with laboratory operations in Nijmegen, The Netherlands, and U.S. 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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