Bladder cancer has a very high cure rate of over 90% when detected early, but the recurrence rate reaches 70%, necessitating continuous management. If discovered late, extensive surgery, such as bladder removal followed by the implantation of an artificial bladder or the use of a urine bag, is required, significantly diminishing the patient's quality of life. However, the urine test kits currently in use have low sensitivity, and cystoscopy, which involves inserting a tube into the urethra to inspect the inside of the bladder, is painful and burdensome, making a convenient and accurate diagnostic technology necessary for patients.
Chung Young-do, a senior researcher at the Biomolecular Recognition Research Center of the Korea Institute of Science and Technology (KIST), noted that a research team, in collaboration with Professor Kang Seok-ho and his team from the Department of Urology at Korea University, developed a urine bladder cancer diagnostic kit that can be conveniently used at home. The research results were published in the international academic journal 'Nature Biomedical Engineering' in November.
The research team designed a new diagnostic kit that detects bladder cancer biomarkers by utilizing the principle of layering water and oil. The difficulty in detecting bladder cancer biomarkers in urine was due to the low concentration of biomarkers and the interference of impurities such as hematuria. The newly developed diagnostic kit operates by transferring a buoyant signal carrier generated from the destruction of a film linked to the biomarker to the oil layer, generating a signal. This design prevents impurities like hematuria from interfering with the signals and maximizes the signal amplification effect for accurate detection of biomarkers.
The research team conducted a double-blind clinical trial involving 80 patients and 25 normal individuals at the Department of Urology at Korea University and confirmed that the sensitivity of the developed diagnostic kit reached 88.8%. This is a significant improvement compared to the existing commercialization methods, which only had a sensitivity of 20%. While early detection of bladder cancer was nearly impossible with existing methods, the newly developed kit was capable of detecting early bladder cancer with high accuracy.
The developed diagnostic kit is expected to reduce unnecessary cystoscopy procedures and to enhance patient survival rates by detecting bladder cancer early, as well as improving life quality. Based on these results, the research team plans to continue exploring products that can be quickly used en masse at comprehensive examination centers and products that can be easily used at home.
Chung Young-do stated, "This study confirmed the possibility of early diagnosis of bladder cancer using a simple bladder cancer diagnostic kit." Professor Kang Seok-ho added, "This study, achieved through clinical translational research between KIST and Korea University, is expected to open new avenues for the development of early diagnostic technologies for various diseases beyond bladder cancer."
Reference materials
Nature Biomedical Engineering (2024), DOI: https://doi.org/10.1038/s41551-024-01298-0