IRVINE, California, and HERSTAL, BELGIUM - September 23, 2014 - MDxHealth SA (NYSE Euronext: MDXH), a leading molecular diagnostic company that develops and commercializes epigenetic tests to improve the diagnosis and treatment of cancer patients, today announced that its ConfirmMDx® for Prostate Cancer test qualifies for Medicare coverage effective November 3, 2014.
The Centers for Medicare and Medicaid Services (CMS) released the final version of the coverage policy issued by Palmetto GBA, the Medicare administrator responsible for the MolDx technology assessment program that evaluated the ConfirmMDx test:
MolDX Title: ConfirmMDx Epigenetic Molecular Assay
LCD#: L35368
As part of an ongoing commitment to ensure that Medicare covers the appropriate use of the ConfirmMDx test, Palmetto GBA expects MDxHealth to continue accruing patients in the prospective, randomized PASCUAL clinical utility trial currently in process, and to enroll providers into it's Certification and Training Registry. The LCD provides for coverage initially limited to patients of physicians enrolled in the ConfirmMDx Registry. MDxHealth will conduct an interim analysis of the PASCUAL study to determine the repeat biopsy rate, and expects to complete the interim analysis in 2015. Provided the interim analysis yields positive results showing a substantially lower repeat biopsy rate, Palmetto will expand physician participation in the ConfirmMDx Registry, effectively increasing the number of Medicare patients covered. If the interim analysis demonstrates poor accrual, or fails to demonstrate a substantially decreased repeat biopsy rate, the LCD indicates that limited coverage will continue until either 1,200 patients have been tested or 3 years from the effective date of the LCD, which ever occurs first. MDxHealth expects to have tested 1,200 patients within the PASCUAL trial and the Registry by Q2 2016. Unrestricted Medicare coverage, with the Registry requirement removed, is expected with favorable PASCUAL trial findings.
"The ConfirmMDx for Prostate Cancer test is an important tool validated to aid urologists with management of patients suspected to harbor undetected prostate cancer and the need for a repeat biopsy. The PASCUAL clinical trial is an opportunity to prospectively demonstrate how urologists utilize the test results in a patient population with a previous negative biopsy result," said principal study investigator Neal Shore, M.D. Medical Director, Carolina Urologic Research Center Partner, Atlantic Urology Clinics, Myrtle Beach, South Carolina. "Prostate cancer is one of the most common cancers in U.S., with 1 in 6 men diagnosed during their lifetime. Prostate cancer can be most effectively treated if caught early, so ConfirmMDx serves a vital role. The ConfirmMDx test provides valuable genomic insights beyond standard pathology review, helping urologists make informed decisions about the need for repeat biopsy on high risk patients."
"We are pleased to announce this important milestone for the ConfirmMDx test, and MDxHealth. The decision by Palmetto GBA's MolDX technology assessment program to cover ConfirmMDx for Medicare beneficiaries under the conditions set forth in the LCD establishes ConfirmMDx as a "reasonable and necessary" test for the management of men suspected to have occult cancer. Medicare's decision will facilitate negotiations with private insurance companies as well," stated Dr. Jan Groen, CEO of MDxHealth. "Initial patient enrollment in the PASCUAL trial has been robust and we are confident this study will yield positive results corresponding to those already reported in the clinical utility study we published earlier this year