THE NEED

Bladder cancer is one of the most common cancers in the Western world, and approximately 70%–80% of newly diagnosed patients present with non-muscle-invasive disease (NMIBC). Approximately 760,000 people in the United States and 1.3 million people in Europe have been diagnosed with bladder cancer and are currently living with the condition. Most patients with non-muscle-invasive bladder cancer undergo local resection of the tumor and require long-term follow-up due to the high risk of recurrence, with follow-up intensity tailored to risk category. Follow-ups include cystoscopy with or without cytology. Cystoscopy procedures detect approximately 70-80% of recurrences, are invasive and painful and are negative in 90% of visits. Both cystoscopy and cytology are subjective, costly and highly dependent on operator expertise. Therefore, there is a clear need for a non-invasive, objective, robust and simple tool to follow-up non-muscle-invasive bladder cancer patients.

Sources
National Cancer Institute. SEER Cancer Stat Facts: Bladder Cancer. Estimated prevalence of bladder cancer in the United States, 2023.

De Angelis R, Demuru E, Baili P, et al.; EUROCARE-6 Working Group. Complete cancer prevalence in Europe in 2020 by disease duration and country (EUROCARE-6): a population-based study. The Lancet Oncology. 2024;25(3):293–307. Supplementary materials, Table A.6.

OUR SOLUTION

Bladder EpiCheck provides patients and clinicians with a simple, objective urine test to detect recurrence of bladder tumors. The test analyzes subtle disease-specific changes in DNA methylation markers, allowing for the detection of high-risk (non Ta-LG) cancers. High risk cancers² are important to catch as they are aggressive and most likely to progress to invasive cancer if not treated immediately. Bladder EpiCheck demonstrated high Negative Predictive Value (NPV), meaning that when receiving a negative Bladder EpiCheck result, there is a very high 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. Bladder EpiCheck can be used in a surveillance regimen to increase confidence in detection of recurrence.