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A research team from the Korea Institute of Science and Technology (KIST) has developed a urine-based diagnostic kit for bladder cancer that can be conveniently used at home. The kit can accurately detect bladder cancer biomarkers without any preprocessing of urine samples.
Bladder cancer has a cure rate of over 90% when detected early, but it has a high recurrence rate of 70%, necessitating continuous monitoring. Late detection often requires major surgeries, such as bladder removal, significantly lowering the patient’s quality of life.
Existing urine test kits have low sensitivity, and cystoscopy, which involves inserting a catheter into the urethra for internal bladder examination, is both painful and burdensome.
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 and amplifies the signal, enabling precise biomarker detection.
In clinical trials conducted with 80 patients and 25 healthy individuals, 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 a revolutionary 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.
The research team is now aiming to develop products for mass and rapid use in comprehensive medical examination centers and easy application at home.
This study demonstrates the potential for early bladder cancer diagnosis using a simple diagnostic kit, reducing the need for unnecessary cystoscopies. This research paves the way for early diagnostic technologies for various diseases beyond bladder cancer.
The research team plans to establish a startup to focus on the commercialization of this bladder cancer diagnostic kit.
More information: Changjoon Keum et al, Diagnosis of early-stage bladder cancer via unprocessed urine samples at the point of care, Nature Biomedical Engineering (2024). DOI: 10.1038/s41551-024-01298-0
