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ConfirmMDx study provides further validation of epigenetic risk profile

MDxHealth has announced that results from a study published in The Prostate further validated ConfirmMDx for Prostate Cancer and showed that the test can provide treating urologists with deeper insights into a patient`s risk for aggressive prostate cancer.

The company said that ConfirmMDx clinical model combines standard clinical risk factors with DNA-methylation intensity of GSTP1, APC and RASSF1 genes to improve patient risk stratification and guide repeat prostate biopsy decisions.  Each of the 102 men enrolled in this multicenter study received a standard 12-core diagnostic biopsy, and the ConfirmMDx test was performed on all biopsy tissue cores. Histopathologic assessment revealed that 20 men had cancer-negative biopsy results, 46 men had low-grade (Gleason Score 6, GS6 or less) cancer and 36 high-grade (GS7 or greater) disease.

ConfirmMDx risk scores were significantly higher in biopsy cores of men with high-grade disease. Moreover, in men with high-grade prostate cancer, the GS6 and cancer-negative biopsy cores also yielded high methylation intensities (both p<0.001). Importantly, even after removing all the high-grade cancer cores and analyzing only the cancer-negative and GS6 cores, men diagnosed with GS7 or greater cancer still had the highest methylation intensities (p<0.001). These results demonstrated the test`s ability to help improve the identification of men with undetected aggressive disease from negative biopsies.

“The ConfirmMDx clinical model is a powerful molecular tool that can help compensate for prostate biopsy limitations and provide a more accurate risk assessment without conducting further invasive procedures,” said Prof. Dr. Sandra Gaston, Department of Pathology and Laboratory Medicine at Tufts University School of Medicine, Boston, Massachusetts. “In addition to ConfirmMDx identifying false-negative biopsy results, the risk score can more accurately predict a patient`s cancer grade upon repeat biopsy. This information is critical to determining who would benefit most from a repeat procedure.”

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