MDxHealth Analytical Validation Study on AssureMDx for Bladder Cancer Published in The Journal of Urology

MDxHealth SA has announced that data demonstrating the clinical potential of its urine-based epigenetic bladder cancer test AssureMDx to aid urologists in the management of patients presenting with hematuria (blood in the urine) has been published in The Journal of Urology.

Prof. Dr. Ellen Zwarthoff, Erasmus MC Cancer Institute and a principal investigator of the published study stated: "Hematuria accounts for approximately 20% of all visits to the urologist, so it is important to distinguish patients at low risk for bladder cancer from those who may have bladder cancer. The data are compelling and strongly support the clinical utility of this non-invasive test that can help reduce unnecessary invasive cystoscopy procedures in patients presenting with hematuria, but at low risk for bladder cancer. Importantly, the test will help identify those patients at highest risk for bladder cancer who may benefit from early detection."

Study details

The AssureMDx for Bladder Cancer test, which analyses DNA methylation of three genes (TWIST1, ONECUT2 and OTX1) in combination with mutation analyses of three others, was used to create an epigenetic profile of 154 urine samples from hematuria patients without (n=80) and with (n=74) bladder cancer. The study demonstrated the test's high negative predictive value (99.2%) for the detection of bladder cancer in this cohort of hematuria patients (van Kessel et al; J Uro 2016).

Assuming a general prevalence rate of 5% for bladder cancer in patients with hematuria, the test generated an impressive 99.2% NPV to rule out the presence of bladder cancer in this study. When DNA mutations are combined with the epigenetic results, and the effect of cytology is estimated, the NPV could further increase to 99.9%. Current diagnostic tools have some limitations, not the least of which are cost and invasiveness, but also these methodologies are prone to miss some small bladder tumors, satellite lesions as well as carcinoma in situ, leaving some patients at risk for undetected cancer. Importantly, with a low prevalence of bladder cancer, the vast majority of patients could avoid an invasive cystoscopy procedure and the associated costs and morbidity.

Dr. Jan Groen, Chief Executive Officer of MDxHealth, added: "The powerful and positive results of this study clearly support the continued development of our non-invasive bladder cancer test. We are currently running a prospective study as part of our ongoing clinical validation strategy, preparing the AssureMDx test for commercial launch as a laboratory developed test in Q4 2016."