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AssureMDx is a noninvasive, urine-based test for the early detection of bladder cancer

The AssureMDx test aids in identifying patients at an increased risk for bladder cancer, allowing for timely urological referrals.

With plans in place to launch a urine-based molecular test for bladder cancer detection next month, Vesica Health is also gearing up to validate a second application in post-treatment patient surveillance.

In that vein, European researchers recently published a study in the journal European Urology Open Science concluding that while further validation in larger cohorts is warranted, the company's AssureDx test has the potential to reduce the use of cystoscopies in patients who have had radiation treatment for muscle-invasive bladder cancer.

The AssureMDx test demonstrated an area under the curve of 0.80 in detecting urinary tract recurrences in MIBC.

According to Vesica, the AssureDx test conferred a statistically significant improvement in the identification of patients at increased risk for bladder cancer over AUA measures alone. Notably, in patients with microhematuria, the assay showed an area under the receiver operating curve of 0.97, with a positive test result resulting in a fivefold increase in the risk of harboring bladder cancer compared to the current risk assessment metrics alone.

Vesica Health’s (Irvine, CA, USA) AssureDx is a noninvasive urine test that assesses genomic changes related to bladder cancer, assisting in the identification of patients who would benefit from a clinical assessment by an urologist.

In patients with microhematuria, a positive result on the test was associated with a 5-fold increase in the risk of patients harboring bladder cancer compared with current metrics alone.