Patients diagnosed with bladder cancer should undergo continuous monitoring based on their risk of recurrence and tumor progression. This monitoring is carried out using cystoscopy, a procedure in which a medical device with a camera (similar to a catheter) is inserted through the urethra, which is associated with some discomfort.

Alternatively, we offer a non-invasive test : the Bladder Epicheck® DNA methylation test . This test is convenient for the patient, as it only requires providing a urine sample.

The Bladder Epicheck® epigenetic kit is based on real-time PCR analysis of DNA present in urine obtained through spontaneous voiding. This test studies a panel of 15 markers that detect changes in DNA methylation specific to bladder tumors.

The most recent studies reveal a sensitivity of 92%, a specificity of 88%, and a negative predictive value of 99.3%, excluding Ta-LG cases (compared to 78,6% for standard urine cytology). This means that, with a negative result, the test rules out the presence of aggressive bladder tumors with over 99% accuracy. According to published data, adding Bladder Epicheck® to the diagnostic protocol significantly increases the accuracy in detecting high-grade bladder cancer from 72.4% to 94.9%. Furthermore, in certain patients and scenarios, this test could reduce the frequency and/or need for cystoscopies (an invasive procedure) without overlooking the presence of aggressive tumors. Even in certain tumor subtypes, such as carcinoma in situ, the performance of this test is superior to traditional cystoscopy.

The results of this novel test were presented at the European Congress of Urology in 2018, and subsequently published in 2019. Since then, multiple publications have confirmed its usefulness.