MDxHealth Epigenetic Biomarkers Show Ability To Confirm The Presence Of Lung Cancer In Sputum Samples

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 Cancer ^TM, to help physicians accurately assess the presence or absence of cancer genes. These important new data will be presented at the 5 ^th 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 ConfirmMDx ^TM 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%.