Point-of-Care Diagnosis of Early-Stage Bladder Cancer Using Urine Samples

Bladder cancer detection relies on invasive cystoscopy and urine cytology, which have several limitations in early diagnosis and frequent monitoring, especially in low-resource settings. A recent study by Keum et al. in Nature Biomedical Engineering described a new point-of-care test leveraging enzyme-based detection of urinary hyaluronidases in unprocessed urine samples.

The researchers developed a novel biphasic system named BLOOM (buoyancy-lifted bio-interference-orthogonal organogel messenger) that separates each urine sample into aqueous and organic layers to enable interference-free detection of hyaluronidase biomarkers. The investigators then performed a double-blind study of 105 clinical samples (60 bladder cancer, 20 other genitourinary diseases, 25 healthy controls). BLOOM achieved 88.3% sensitivity and 88.9% specificity (AUC=0.93, p<0.0001). The system successfully detected early-stage non-muscle invasive bladder cancer with 90.4% accuracy for Ta stage tumors. The investigators also demonstrated consistent performance in hematuria samples through the biphasic design. Pre/post-surgical monitoring showed significant decreases in signal after tumor removal (p=0.0006).

Importantly, the BLOOM device includes low-cost components, costing only a few dollars per test. The study shows the promise of sensitive early detection of bladder cancer through a simple, low-cost urine test suitable for at-home monitoring. Future prospective studies are needed for validation in clinical settings.

Written by: Bishoy M. Faltas, MD, Director of Bladder Cancer Research, Englander Institute for Precision Medicine, Weill Cornell Medicine

Reference:

Keum C et al. (2024). Diagnosis of early-stage bladder cancer via unprocessed urine samples at the point of care. Nat Biomed Eng. https://doi.org/10.1038/s41551-024-01298-0

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