Konkuk University, Konkuk University Medical Center, and StemExOne Develop Urine-Based Diagnostic Approach as an Alternative to Endoscopy

[Korea University News Reporter Lee Jung-hwan] A research team led by Prof. Ssang-Goo Cho of Konkuk University’s Department of Stem Cell and Regenerative Biotechnology, in collaboration with Prof. Aram Kim of the Department of Urology at Konkuk University Medical Center and StemExOne, has developed a low-cost, non-invasive diagnostic technology for bladder cancer using DNA extracted from urinary cell pellets (cpDNA).

The study, conducted through a university-hospital-industry collaboration, was published online on March 3 in Laboratory Investigation, an international journal ranked within the top 10% in the field of pathology.

From left: Dr. Jae-Kwon Seok of Konkuk University, researcher Hee-Jung Kwak, Prof. Aram Kim of Konkuk University Medical Center, and Prof. Ssang-Goo Cho of Konkuk University, CEO of StemExOne.

The research team isolated cell pellet DNA (cpDNA) from the urine of patients with non-muscle-invasive bladder cancer (NMIBC) using a low-cost, non-invasive method and analyzed genetic mutations through next-generation sequencing (NGS).

The results showed a high degree of similarity between tumor tissue and urinary cpDNA, with frequent mutations identified in key bladder cancer-associated genes, including FGFR3, TTN, and LEPROTL1.

In particular, a comparison of tumor mutational burden (TMB) revealed no significant difference between urinary cpDNA and tumor tissue, suggesting that cpDNA could serve as an effective biomarker for the early detection of bladder cancer and surveillance for recurrence.

Bladder cancer is currently diagnosed primarily through cystoscopy and tissue biopsy, procedures that require instruments to be inserted through the urinary tract and can impose considerable physical and financial burdens on patients. In contrast, the cpDNA-based method developed by the research team enables precise cancer detection using only a urine sample, offering a diagnostic approach with significantly less pain and procedural risk.

The technology is also expected to have broader potential for the early detection of various diseases in the future.

The research team stated, “This study demonstrates the potential to detect disease at an early stage and effectively monitor recurrence by directly analyzing DNA obtained from a patient’s urine.”

They added, “Although further research and standardization will be required before clinical application, we expect this low-cost, non-invasive technology for early disease detection and monitoring to have broad potential for use in clinical practice.”

The study was jointly conducted by Prof. Ssang-Goo Cho, Dr. Jae-Kwon Seok, and researcher Hee-Jung Kwak of Konkuk University, together with Prof. Aram Kim of Konkuk University Medical Center.