TEST:

Bladder EpiCheck®

Bladder EpiCheck is a urine test to detect recurrence of bladder tumors. The test analyzes subtle disease-specific changes in DNA methylation markers, allowing for the detection of 92%1 of the high-risk (non Ta-LG) cancers. It demonstrated Negative Predictive Value (NPV) of 99%1 for high-risk cancer, meaning that when receiving a negative Bladder EpiCheck result, there is 99%1 chance that no high-risk cancer is present. Bladder EpiCheck is an objective molecular test meaning that it does not rely on human interpretation. The result is a clear positive/negative for presence of bladder cancer, with an additional numerical results between 0-100. Bladder EpiCheck can be used in a surveillance regimen to increase confidence in detection of recurrence and/or to reduce amount of cystoscopies. Bladder EpiCheck® is CE-marked and available in Europe. It is currently not cleared in the US and may only be used for investigational purposes only.