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 cancers. The test demostrated high sensitivity of 91% in High grade cancers that are important to catch as they are aggressive and are likely to progress to invasive cancer if not treated immediately. Bladder EpiCheck demonstrated high Negative Predictive Value (NPV) of 99% for high-grade cancer, meaning that when receiving a negative Bladder EpiCheck result, there is a very high chance that no high-grade 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.

Indication: The Bladder EpiCheck test is an in vitro diagnostic device for the detection of DNA methylation patterns in urine that are associated with urothelial carcinoma. It is intended for use as a non-invasive method for monitoring of tumor recurrence in conjunction with standard diagnostic procedures in patients previously diagnosed with bladder cancer and/or upper tract urothelial carcinoma. Additionally, Bladder EpiCheck is intended for use as an aid in the detection of bladder cancer and upper tract urothelial carcinoma (UTUC), in patients presenting with hematuria and/or other urinary tract symptoms and/or findings with a suspicion of malignancy, in conjunction with standard diagnostic procedures.

Bladder EpiCheck®, CE-marked and available in Europe for primary and recurrent bladder cancer and upper tract urinary cancer, and FDA 510(k) cleared for bladder cancer recurrence in the United States.