MDxHealth SA, a leading molecular diagnostic company that develops and commercializes epigenetic tests to improve the diagnosis and treatment of cancer patients, today announced that the company's MGMT (O6-methylguanine-DNA methyl transferase) test, PredictMDx™ for Glioblastoma, used to identify patients most likely to respond to targeted therapy, has been included in the 2013 National Comprehensive Cancer Network (NCCN) Guidelines. The NCCN is an alliance of 23 world-leading cancer centers. The new guidelines are published online at nccn.org.
The American Medical Association (AMA) has also awarded the PredictMDx for Glioblastoma test with Tier 1 reimbursement code. The AMA Current Procedural Terminology (CPT®) Editorial Panel awarded a Tier 1 Code, 81287, to MGMT methylation analysis following an application from MDxHealth. Tier 1 codes are assigned to report gene-specific and genomic procedures and are considered category 1 codes.
"We are extremely pleased with the clinical support for our MGMT test. Acceptance into the NCCN treatment guidelines establishes the test within the "standard of care" for the improved management of glioblastoma patients, and the award of the Tier 1 CPT code by the AMA provides a clear basis for comprehensive reimbursement," stated Dr. Jan Groen, CEO of MDxHealth. "In addition, the clinical validation study for MGMT, branded PredictMDx for Glioblastoma, and the accompanying peer-reviewed publication of the data, further demonstrate the clinical importance and validity of the MGMT test for treatment decision making."
In the international prognostic Phase III (RTOG 0525) validation study, published in the Journal of Clinical Oncology (10.1200/JCO.2013.49.6968*), the PredictMDx for Glioblastoma test successfully identified newly diagnosed glioblastoma patients who are more likely to live longer and have a longer progression free time period following treatment with temozolomide.
"The publication of these results confirms the value of measuring the methylation status of the MGMT gene in a prospective manner," explained Prof. Dr. Monika Hegi, PhD, Head Laboratory of Brain Tumor Biology and Genetics, Neurosurgery, University Hospital Lausanne, Switzerland. "The MDxHealth MGMT test was successfully carried out prior to patient randomization which allowed for proper patient stratification. Newly diagnosed grade IV glioblastoma patients who have a methylated MGMT gene experience a survival and disease progression benefit from the current standard-of-care treatment. This study emphasizes the need to test glioblastoma patients for MGMT promoter methylation as a stratification factor in future clinical studies."
About PredictMDx for Glioblastoma
MDxHealth's PredictMDx for Glioblastoma (MGMT) test provides actionable information to oncologists seeking to provide personalized treatment of patients with brain cancer. The test assesses the methylation status of the MGMT gene, which is crucial to promoting DNA repair. If the MGMT gene is methylated, cancer patients have shown improved response to alkylating drug therapy. Studies on thousands of patients have shown that PredictMDx for Glioblastoma can help identify patients that are likely to respond to the most commonly used class of brain cancer drugs (alkylating agents).
MDxHealth (mdxhealth.com) is a molecular diagnostics company that develops and commercializes advanced epigenetic tests for cancer assessment and the personalized treatment of patients. The company's first commercial product, ConfirmMDxTM for Prostate Cancer, has been shown to help distinguish patients who have a true-negative biopsy from those who may have undetected cancer, thereby aiding in the reduction of unnecessary repeat biopsies. MDxHealth helps to address a large and growing unmet medical need for better cancer diagnosis and treatment information. The company has a proprietary platform and a strong epigenetic product pipeline focused on the development of products for prostate, brain and lung cancers. The company is based in Irvine, California with a European headquarters in Herstal, Belgium.
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