Promis Diagnostics, Inc., a molecular diagnostics company focused on early cancer diagnosis, recently presented clinical validation data for CystoChek, at the 2021 American Urological Association (AUA) Annual Meeting.
CystoCheck is a proprietary urine-based DNA methylation test of PENK for bladder cancer (BCa) detection in hematuria.
Researchers from Genomictree Inc, Chungnam National University Hospital (Daejeon, South Korea), and Promis previously discovered aberrant methylation of PENK, a potential biomarker, frequently occurs in bladder cancer. Two separate clinical studies were conducted to demonstrate and evaluate the performance of CystoChek. First, in a retrospective study, the data showed a sensitivity of 91% with a specificity of 93.5% in detecting Ta high-grade and greater stages of BCa in 567 hematuria patients. Second, in a prospective study, the data demonstrated a sensitivity of 93.2% with a specificity of 90.4% in detecting all of Ta high-grade and greater stages of BCa in 183 hematuria patients, who then received cystoscopy procedures.
“CystoChek is an accurate and cost-effective bladder cancer detection tool that we hope to present to the community with no delay. The sensitivity of the urine DNA test for early detection of bladder cancer will provide significant benefits not only to the patients but also to healthcare stakeholders,” says Sungwhan An, CEO of Promis.