Clinical Validation of the Proenkephalin (PENK) Methylation Urine Test for Monitoring Recurrence of Non–muscle-invasive Bladder Cancer

Irvine, California, March 7, 2024

In a groundbreaking study published in European Urology Open Science, researchers have validated a novel urine-based test for monitoring the recurrence of non-muscle-invasive bladder cancer (NMIBC), offering a less invasive and potentially more accurate method for patient follow-up care. The test, called the EarlyTect BC test, based on the methylation levels of the proenkephalin (PENK) gene in urine, outperforms current surveillance methods, including cytology and the NMP22 test, in detecting recurrent bladder cancer.

The EarlyTect BC (mePENK) test marks a significant breakthrough in the surveillance of non-muscle-invasive bladder cancer (NMIBC). This novel urine-based diagnostic tool leverages the detection of methylation levels in the proenkephalin (PENK) gene to monitor the recurrence of NMIBC with a notable degree of accuracy and less invasiveness compared to traditional methods. This innovative approach not only boasts a sensitivity of 76.3% and a specificity of 85% in detecting NMIBC recurrence, significantly surpassing the performance of existing surveillance methods like cytology and the NMP22 test, but it also demonstrates significant prognostic value. Patients with positive results from the EarlyTect BC (mePENK) test experience significantly shorter recurrence-free intervals than those with negative outcomes, indicating a heightened risk of cancer recurrence.

The introduction of the EarlyTect BC (mePENK) test into clinical practice promises to transform NMIBC follow-up care. By providing a non-invasive, accurate method for detecting recurrence, particularly in high-risk patients, this test has the potential to streamline surveillance protocols, minimize the need for frequent cystoscopies, and significantly improve the quality of life for individuals living with NMIBC.
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