Promis Dx Presents Validation Data for Urine DNA Test for Bladder Cancer Detection in Hematuria
PASADENA, Calif., Sept. 10, 2021 /PRNewswire/ -- Promis Diagnostics, Inc., a molecular diagnostics company focused on early cancer diagnosis, recently presented clinical validation data for CystoChek, its proprietary urine-based DNA methylation test of PENK for bladder cancer (BCa) detection in hematuria, at the 2021 American Urological Association (AUA) Annual Meeting.
Researchers from Genomictree Inc, Chungnam National University Hospital (Daejeon, South Korea), and Promis previously discovered that aberrant methylation of PENK, a potential biomarker, frequently occurs in bladder cancer. To further demonstrate the validity of their discovery, and to evaluate the performance of CystoChek, two separate clinical studies were conducted. First, in a retrospective study, the data showed a sensitivity of 91.0% 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'', said Sungwhan An, CEO of Promis.
A copy of the presentation was posted on the meeting's website. Also, the poster will be available at Promis' website at www.promisdx.com after the AUA Annual Meeting.
About Promis Diagnostics
Promis Diagnostics, Inc. is a molecular diagnostics company aiming to perform clinical trials and commercialize various biomarker-based IVD tests for early detection of cancers. It is a CLIA-certified and CAP-accredited laboratory in Pasadena, California, funded by Genomictree (a Korean public company) and a third-party venture capital. For more information, visit www.promisdx.com and follow us on social media at: https://www.linkedin.com/in/promisdx and facebook.com/promisdx.
SOURCE Promis Dx
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