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 procedures that are invasive and painful, are negative in 90% of cases, and detect only 70-80% of recurrences. Both cystoscopy and cytology are subjective, costly and highly dependent on the operator expertise. Therefore, there is a clear need for a non-invasive, robust and simple tool to follow-up non-muscle-invasive bladder cancer patients.
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, 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.
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