THE NEED

Bladder cancer is the 5th most common cancer in the western world, and 70%-80% of the patients are diagnosed with non-muscle invasive disease.  There are estimated 400,000 to 800,000 active bladder cancer patients in the United States, as well as 1 to 2 million in Europe, who undergo local resection of the tumor and then have 1-4 follow-up visits each year due to the high recurrence rate of the disease. Follow-ups include cystoscopy with or without cytology. Cystosocpy procedures detect approximately 70-80% of recurrences, are invasive and painful and are negative in 90% of cases. Both cystoscopy and cytology are subjective, costly and highly dependent on the 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.

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.