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Thomas Flaig, MD


Detecting Bladder Cancer in Patients With Hematuria: Novel Urine DNA Methylation Test Under Study

By: Sarah Campen, PharmD
Posted: Friday, October 28, 2022

Researchers in Norway have developed a novel urine DNA methylation test for detecting bladder cancer in patients with hematuria and suggest it may potentially spare some individuals invasive cystoscopy in the future, according to a study published in Clinical Epigenetics. The biomarker panel, called BladMetrix, appears to demonstrate diagnostic accuracy and sensitivity across all tumor grades and stages.

“Given the high accuracy, cost efficiency, noninvasive nature, and straightforward implementation, BladMetrix shows promise as a clinical test for urine-based detection of bladder cancer in hematuria patients,” stated Guro Elisabeth Lind, MD, of Oslo University, and colleagues.

In this study, 32 candidate biomarker individuals were identified from methylome sequencing of 16 urologic cell lines. Following the targeted methylation analysis of 60 tissue samples, the 8 “most promising” biomarkers were integrated to form the BladMetrix panel.

The performance of BladMetrix in urine samples was evaluated in a discovery series (n = 112) consisting of patients with bladder cancer, those with other urologic cancers, and healthy individuals. The panel achieved a sensitivity of 95.7% and a specificity of 94.7%.

The cutoff to score a positive test, identified from the discovery series, was validated in an independent prospective and blinded series of urine samples from patients with gross hematuria (n = 273). In the complete hematuria urine series, 93.0% of patients (n = 254) had a conclusive test result. Among those patients, BladMetrix achieved a sensitivity of 92.1%, a specificity of 93.3%, and a negative predictive value of 98.1% for the detection of bladder cancer. According to the authors, the BladMetrix test has the potential to reduce the number of required cystoscopies by 56.4%.

Disclosure: For full disclosures of the study authors, visit

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