Diagnosis and recurrence prediction power of the urinary biomarker assay, OncoUrine
OncoUrine – a urinary test comprised of gene mutation and methylation biomarkers – has been further validated for use in the diagnosis and surveillance of bladder cancer. The results of this clinical trial were published in BMC Medical.
Bladder cancer is the most common malignancy of the urinary tract and can be divided into non-muscle invasive bladder cancer (NMIBC), where cancer cells are limited to the inner lining of the bladder, or muscle-invasive bladder cancer (MIBC), which describes cancer growth into the deeper muscle layer of the bladder. In a clinical setting, patients with suspected NMIBC typically undergo imaging, cytology and cystoscopy, followed by pathological assessment if suspicious tissues are detected. The high recurrence rate of NMIBC necessitates extensive follow-up with invasive cystoscopies and, when repeated over a period of years, imposes significant negative effects on the patient’s quality of life.
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In this study, the authors investigated the performance of OncoUrine for the diagnosis and recurrence prediction of NMIBC in a cohort of 203 patients, including 60 patients with hematuria and 143 NMIBC patients under recurrence surveillance. The OncoUrine panel encompasses hotspot mutations in 17 genes as well as ONECUT2, a methylation biomarker. Urine samples were taken from the patients for use with OncoUrine prior to cystoscopy. For bladder cancer diagnosis, the OncoUrine panel demonstrated a sensitivity of 80%, a specificity of 91.9% and positive and negative predictive values (PPV and NPV) of 72.7% and 94.4%, respectively. As OncoUrine identified 34 true negative patients out of 47, the results suggest that the biomarker panel could reduce the number of cystoscopies by 72.3%.
For recurrence diagnosis in NMIBC, sensitivity, specificity, PPV and NPV of 100%, 68.2%, 22.9% and 100% respectively were achieved using OncoUrine. As 58 true negatives were identified with OncoUrine out of a possible 93, the panel may hold the potential to reduce 62.4% of cystoscopies in patients under recurrence surveillance.
Overall, the study demonstrated the promising applications of OncoUrine in the clinical management of NMIBC; the use of this biomarker panel will help to reduce the number of unnecessary cystoscopies.
Source: Huang H, Liu A, Liang Y et al. A urinary assay for mutation and methylation biomarkers in the diagnosis and recurrence prediction of non-muscle invasive bladder cancer patients. BMC Med. 21(357), (2023).
