At-Home Bladder Cancer Test: New Urine-Based Kit May Enable Early Diagnosis, Study Finds
The research team has developed a urine-based diagnostic kit for bladder cancer that can be conveniently used at home. This kit can accurately detect bladder cancer biomarkers without any preprocessing of urine samples. The findings are published in nature biomedical engineering.
The research team designed an innovative diagnostic kit by utilizing the principle of water and oil layering to detect bladder cancer biomarkers. Biomarker detection in urine has been challenging due to the low concentration of biomarkers and interference from impurities like hematuria. The newly developed kit overcomes these issues by employing a mechanism where a film bonded to the biomarker is broken, releasing a buoyant signal carrier that moves to the oil layer and emits a detectable signal. This design prevents interference from impurities like hematuria and amplifies the signal, enabling precise biomarker detection.
In clinical trials conducted with 80 patients and 25 healthy individuals at Korea University’s Department of Urology using a double-blind methodology, the diagnostic kit achieved a sensitivity of 88.8%. This is a significant improvement compared to the mere 20% sensitivity of existing commercial tests. Notably, while conventional methods are almost incapable of diagnosing early-stage bladder cancer, the new kit accurately detects even early-stage cases.
This diagnostic kit offers an approach for the early detection of bladder cancer through non-invasive and simple urine tests. It is expected to reduce the need for unnecessary cystoscopy, improve survival rates through early detection, and enhance patients' quality of life.
Dr. Youngdo Jeong of the Center for Advanced Biomolecular Recognition the Korea Institute of Science and Technology said, “This study demonstrates the potential for early bladder cancer diagnosis using a simple diagnostic kit, reducing the need for unnecessary cystoscopies.”
Reference: Keum, C., Yeom, H., Noh, T.I. et al. Diagnosis of early-stage bladder cancer via unprocessed urine samples at the point of care. Nat. Biomed. Eng (2024). https://doi.org/10.1038/s41551-024-01298-0
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