> Bladder Epicheck®
The Bladder EpiCheck® test is an in vitro diagnostic device for the detection of DNA methylation patterns in urine that are associated with bladder cancer. It is intended for use as a noninvasive method for monitoring for tumor recurrence in patients previously diagnosed with bladder cancer.
Bladder Epicheck, developed by Nucleix, it is based on a real-time PCR analysis, requiring only small amounts of DNA. It consists of a panel of 15 informative biomarkers which allows the detection of DNA methylation changes to distinguish between healthy and cancer tissue.
An algoritm also developed by Nucleix is applied to these methylation patters, ouputs yes/no + Episcore (0-100) representing metylation levels in the urine sample. A higher value of 60 units is considered positive or high risk, where as a lower value than 60 units means low risk or negative, in terms of tumor recurrence.
This technique requires a simple setup, standard equipment and it is automatable providing an accurate and non-observer dependent result.
The last Bladder Epicheck study shows the sensitivity of the test is 92%, the specificity is 99% and a negative predictive value of 99% (excluding ta-LG cases).