Validation Study Data Published in The Journal of Urology
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 one of the ConfirmMDxfor Prostate Cancer epigenetic genes is independently associated with risk of recurrence in patients with early prostate cancer (PCa). The results from this study, published in The Journal of Urology [The Journal of Urology (2014), doi:10.1016/j.juro.2014.04.082], suggest that epigenetic analysis could play a clinical role in identifying patients who have a slow growing cancer eligible for active surveillance from those with a higher risk of recurrence who may benefit from a more aggressive therapeutic approach.
One of the most significant challenges in diagnosing early stage PCa is proper staging and grading of the patients in order to choose the best treatment plan. Current methods such as clinical staging, PSA serum level and biopsy tissue Gleason score are helpful, but have limited prognostic value. Therefore, more accurate and objective prediction of PCa disease recurrence is very important. The gene glutathione S-transferase Pi 1 (GSTP1) is one of the three genes in the ConfirmMDx test and previous studies have indicated that this gene has been associated with different stages of PCa.
"The results of this independent validation study confirm previous data presented at the 2014 ASCO GU Cancer Symposium demonstrating the prognostic value of our ConfirmMDx genes," stated Prof. Dr. Wim van Criekinge, Chief Scientific Officer of MDxHealth. "Furthermore, they illustrate the clinical importance of using epigenetic biomarkers, like GSTP1, to not only identify patients with prostate cancer but also inform the treating urologist about the aggressiveness of the disease for treatment decision making."
The study, conducted by researchers from Johns Hopkins University Medical Center, evaluated the prognostic value of nine epigenetic genes using tissue from 452 patients (259 cases, 193 controls) presenting with biochemical recurrence, clinical recurrence, systemic metastases, or who died of their prostate cancer in a nested case-control study of patients surgically treated for clinically localized PCa. Out of the nine genes, the data showed that higher GSTP1 methylation was the only one significantly associated with an increased risk of recurrence, especially for men with early stage PCa.