Date: 2016-01-19
Type of information: Publication of results in a medical journal
phase:
Announcement: publication of results in The Journal of Urology
Company: MDxHealth (Belgium)
Product: AssureMDx™ for bladder cancer
Action
mechanism: diagnostic test. This epigenetic bladder cancer test is a non-invasive, urine-based DNA methylation test designed to help rule out the presence of bladder cancer, sparing many patients unnecessary invasive and potentially harmful procedures, while aiding in the identification of high-risk patients requiring further examination. The test analyses DNA methylation of three genes (TWIST1, ONECUT2 and OTX1) in combination with mutation analyses of three others.
Disease: bladder cancer
Therapeutic area: Cancer - Oncology - Diagnostic
Country:
Trial details:
Latest
news: On January 19, 2016, MDxHealth 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 haematuria (blood in the urine), has been published in The Journal of Urology. MDxHealth is preparing the AssureMDx test for commercial launch as a laboratory developed test in Q4 2016.
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 haematuria 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 haematuria patients (van Kessel et al; J Uro 2016).
Assuming a general prevalence rate of 5% for bladder cancer in patients with haematuria, 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.
