Diagnosing bladder cancer at an early stage is critical and not only can increase patient survival rates but can also contribute to reducing healthcare costs. Current guidelines recommend cystoscopy and imaging examinations for almost all patients presenting with hematuria for initial diagnosis of bladder cancer, but it is invasive, inconvenient, economically burdensome for patients, and frequently fails to detect early-stage bladder cancer. There is therefore an urgent need for a sensitive and precise technique to diagnose early bladder cancer effectively among patients with hematuria

Investigators studied a novel biomarker called aberrant PENK methylation (mePENK), which has shown a high clinical correlation with bladder cancer in previous studies. The first of two independent studies focused on developing a highly sensitive methylation test for mePENK using urine DNA and evaluating its effectiveness in diagnosing bladder cancer in patients within the hematuria population. The cutoff value for the mePENK test was initially determined in a case-control study involving 175 bladder cancer patients and 143 non-malignant hematuria patients. The test exhibited a sensitivity of 86.9% and a specificity of 91.6% in distinguishing bladder cancer from non-malignant hematuria cases

A subsequent independent prospective clinical performance study comprising 366 hematuria patients scheduled for cystoscopy compared the mePENK test results with the cystoscopy findings and histological analysis as the reference standards. The overall sensitivity of the test in detecting 38 cases of bladder cancer at all stages was 84.2%, while the specificity reached 95.7%. Notably, the test demonstrated a sensitivity of 92.3% in detecting high-grade and advanced-stage bladder cancer

Although the FDA (USA) has approved several urine biomarker-based products, these methods have not been effectively utilized for early bladder cancer diagnosis. There are some in vitro molecular diagnostic techniques that measure genetic and epigenetic biomarkers for bladder cancer that are undergoing clinical trials, but they have yet to provide sufficient clinical evidence for the initial diagnosis of primary bladder cancer

Bladder cancer is the sixth most common cancer in the world. Bladder cancer has a five-year survival rate of over 80% when detected early, but this rate significantly declines as it progresses to advanced stages, necessitating bladder removal and having a high risk of recurrence. As a result, bladder cancer ranks among the most expensive cancers to treat and manage

Source: https://www.news-medical.net/news/20230814/New-diagnostic-tool-could-revolutionize-early-bladder-cancer-detection.aspx