Reviewed by Lexie CornerApr 7 2025
A research team led by Dr. Youngdo Jeong from the Korea Institute of Science and Technology’s Center for Advanced Biomolecular Recognition (KIST, President Oh Sang-Rok), in collaboration with Professor Seok-Ho Kang’s team from the Department of Urology at Korea University College of Medicine, has developed a urine-based diagnostic kit for bladder cancer that is designed for home use.
The kit includes a container with a film, a compact optical device for attaching a smartphone, and a diagnostic app. Image Credit: Korea Institute of Science and Technology
Bladder cancer has a high survival rate of over 90 % when diagnosed early; however, it has a recurrence risk of 70 %, requiring continuous monitoring. Late-stage diagnosis often leads to invasive procedures, such as bladder removal or the use of a urine pouch, which significantly affect the patient's quality of life.
Currently, conventional urine tests for bladder cancer have low sensitivity, and cystoscopy, a procedure that involves inserting a catheter into the urethra to examine the bladder, is painful and time-consuming. This highlights the need for an accessible and accurate diagnostic solution for patients.
The research team developed a novel diagnostic kit that utilizes the water and oil layering principle to detect bladder cancer biomarkers. Detecting biomarkers in urine has been challenging due to the low concentration of biomarkers and interference from contaminants like blood.
The new kit overcomes these challenges by using a mechanism that disrupts a film attached to the biomarker, releasing a buoyant signal carrier that rises to the oil layer, generating a detectable signal. This design helps eliminate interference from contaminants like hematuria and enhances the signal, ensuring accurate biomarker identification.
Clinical studies conducted at Korea University's Department of Urology, with 80 patients and 25 healthy individuals, demonstrated that the diagnostic kit achieved an 88.8 % sensitivity using a double-blind approach. This is a significant improvement over conventional commercial tests, which have a sensitivity of only 20 %. Additionally, the new kit can detect early-stage bladder cancer, which current methods often fail to do.
This diagnostic kit provides a simple, non-invasive urine test for the early detection of bladder cancer. It has the potential to reduce the need for cystoscopies, improve survival rates through early detection, and enhance patients' quality of life. Moving forward, the research team plans to develop solutions for widespread use in medical centers and for easy home use.
This study demonstrates the potential for early bladder cancer diagnosis using a simple diagnostic kit, reducing the need for unnecessary cystoscopies. This research, a result of translational studies between KIST and Korea University, paves the way for early diagnostic technologies for various diseases beyond bladder cancer.
Dr. Youngdo Jeong, Principal Research Scientist, Center for Advanced Biomolecular Recognition, Korea Institute of Science and Technology
Dr. Youngdo Jeong and Professor Seok Ho Kang, in collaboration with Dr. Dong Jin Lee of the Korea Institute of Machinery & Materials, plan to establish a startup called "FloatBioscience" focused on commercializing the bladder cancer diagnostic kit, which is designed for mass production. The startup was selected as a preliminary convergence startup team for the 2024 NST Convergence Startup Challenge.
This study was funded by the Ministry of Science and ICT (Minister Sang Im Yoo) through KIST's major project and National Research Foundation (NRF) programs (2023R1A2C100438911).
Journal Reference:
Keum, C., et al. (2025) Diagnosis of early-stage bladder cancer via unprocessed urine samples at the point of care. Nature Biomedical Engineering. doi.org/10.1038/s41551-024-01298-0