Urine-Based Bladder Cancer Diagnostic Kit to Reduce Need for Unnecessary Cystoscopies

Bladder cancer has a high cure rate of over 90% when detected early, but it is characterized by a recurrence rate of 70%, which requires continuous monitoring. Late-stage detection often results in major surgeries, such as bladder removal and the use of an artificial bladder or urine pouch, which significantly impact the patient’s quality of life. However, current urine test kits are not very sensitive, and cystoscopy, which involves inserting a catheter into the urethra to examine the bladder, is both painful and inconvenient. This situation highlights the critical need for a simple yet reliable diagnostic method for patients. Now, a new urine-based diagnostic kit has been developed that can accurately detect bladder cancer biomarkers without the need for preprocessing the urine samples.

This innovative diagnostic tool was developed by a research team at the Korea Institute of Science and Technology (KIST, Seoul, Republic of Korea), using a method based on water and oil layering to detect biomarkers of bladder cancer. Detecting biomarkers in urine has been challenging due to their low concentration and interference from impurities like hematuria. The newly designed kit overcomes these obstacles by employing a mechanism in which a film bonded to the biomarker breaks apart, releasing a buoyant signal carrier that moves to the oil layer and emits a detectable signal. This design eliminates interference from impurities like hematuria and amplifies the signal, allowing for accurate biomarker detection. In clinical trials involving 80 patients and 25 healthy individuals, conducted with a double-blind approach, the diagnostic kit achieved a sensitivity of 88.8%, which is a substantial improvement over the mere 20% sensitivity of existing commercial tests.

Image: The kit includes a container with a film, a compact optical device for attaching a smartphone, and a diagnostic app (Photo courtesy of KIST)

Importantly, while traditional methods are almost unable to diagnose early-stage bladder cancer, the new kit is effective in identifying even early-stage cases. This diagnostic tool offers a groundbreaking approach for the early detection of bladder cancer through a simple, non-invasive urine test. It is expected to reduce the reliance on cystoscopy, improve survival rates through early detection, and enhance patients’ quality of life. Building on these promising results, the research team plans to develop products suitable for mass use in comprehensive medical centers and for easy home application.

“This study demonstrates the potential for early bladder cancer diagnosis using a simple diagnostic kit, reducing the need for unnecessary cystoscopies,” said Dr. Youngdo Jeong from KIST who led the research team.

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