Data Presented at the EORTC - NCI - ASCO Annual Meeting on Molecular Markers in Cancer Provides Evidence of Impressive Biomarker Performance
IRVINE, Calif. & LIEGE, Belgium--(BUSINESS WIRE)-- MDxHealth SA (NYSE Euronext: MDXH), a leading molecular diagnostics company in the field of personalized cancer treatment, today announced the results of a study indicating that several of its epigenetic biomarkers are able to confirm the presence of non-small cell lung cancer (NSCLC) from routinely collected sputum samples of patients with stages I-IV of the disease. MDxHealth is developing a molecular diagnostic test, ConfirmMDx for Lung CancerTM, to help physicians accurately assess the presence or absence of cancer genes. These important new data will be presented at the 5th EORTC - NCI - ASCO Annual Meeting on Molecular Markers in Cancer in Brussels, Belgium (October 27-29)
In this particular NSCLC study based on samples from 92 patients, epigenetic analysis of MDxHealth’s proprietary biomarker RASSF1A, in combination with three other markers (TAC1, GREM1 and HOXA9), resulted in high sensitivity and specificity values of 75-80% and 90-96%, respectively. MDxHeath plans to conduct additional clinical studies to further optimize its ConfirmMDxTM lung cancer test.
“The results of this study clearly show that our epigenetic biomarkers can be used to detect the presence of NSCLC in patients with various stages of disease using a non-invasively collected specimen. Early diagnosis of NSCLC is a clear unmet medical need and critical for potential curative treatment.,” explained Dr. Jan Groen, CEO of MDxHealth.
About the Study
The study was designed to analyze the epigenetic profile of routinely collected sputum samples from patients at risk for NSCLC using methylation specific PCR (MSP). Samples were collected from 40 patients with different stages of NSCLC and 52 symptomatic subjects screened for lung cancer but found to be cancer-free served as controls. For all samples, the epigenetic prolife of 11 genes was defined by MSP. The RASSF1A gene alone showed sensitivity and specificity values of 60% and 96%, respectively. A combination of RASSF1A with other MDxHealth candidate gene markers resulted in a composite sensitivity between 75 to 80% and specificities between 90 to 96%.
MDxHealth is a leading molecular diagnostics company that develops and commercializes oncology-based molecular diagnostic testing for personalized medicine. The company's tests are based on proprietary gene methylation technology and assist physicians with the diagnosis of cancer, prognosis of recurrence risk, and prediction of response to a specific therapy. More information can be found on the Company website: www.mdxhealth.com or on twitter at the following address: www.twitter.com/mdxhealth
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.
Dr. Jan Groen, CEO
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INDUSTRY KEYWORDS: Health Clinical Trials Oncology