MDxHealth SA announced positive data from two abstracts demonstrating the prognostic value of its ConfirmMDx® for Prostate Cancer test at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) 7-9 January 2016 in San Francisco. The data, presented in two separate poster presentations demonstrate: ConfirmMDx test's ability to detect an epigenetic field effect associated with the presence of anterior-predominant tumors that was missed in a previous negative biopsy; ConfirmMDx test's ability to identify patients likely to harbor clinically significant prostate cancer from negative biopsy tissue. In histopathology positive biopsies the test showed a better separation between men with aggressive prostate cancer from those men with indolent disease.

There is increasing awareness that anterior-predominant prostate cancers (PCa) are poorly sampled by 12-core transrectal ultrasound-guided (TRUS) prostate needle biopsies. Approximately one-fifth of all prostate tumors occur in this area, and many are high grade and extend beyond the prostatic capsule. Seven patients, with at least one prior negative TRUS biopsy, were subsequently diagnosed with anterior-only PCa based on a transperineal mapping template prostate biopsy (MTPB).

Among these, six (86%) were methylation positive at initial biopsy, suggesting that the field effect from these anterior-predominant PCa extends to the region of TRUS biopsy sampling. Previous diagnostic studies have established the utility of ConfirmMDx as a significant, independent predictor of prostate cancer, with a negative predictive value (NPV) of 90% for all cancers, and a NPV of 96% for significant cancers. These data further validate the prognostic value of ConfirmMDx.

A training cohort of methylation-positive men with a negative index biopsy followed by either a Gleason score (GS) > or = 7 (n = 43) or cancer-negative (n = 226) repeat biopsy was evaluated. Using the initial negative biopsy, men were stratified for the likelihood of harboring high-grade PCa focusing on a methylation intensity algorithm involving GSTP1, RASSF1 and APC. This algorithm was validated in a cohort of 102 men, with either a PCa-free (n = 20), GS6 (n = 46), or GS > or = 7 (n = 36) biopsy.