Bladder cancer has a high cure rate, with a five-year survival rate of 95 percent when detected early. However, bladder cancer is difficult to manage and deadly, with a recurrence rate of up to 70 percent. In particular, late diagnosis often requires the removal of the entire bladder, the creation of an artificial bladder, or the use of a urine bag, significantly lowering the patient's quality of life.
A research team, led by Professors Kang Seok-ho, Shim Ji-seong, Roh Tae-il, and Yoon Seong-gu from the Department of Urology at Korea University Anam Hospital and Drs. Jeong Young-do, Lee Kwan-hee, Keum Chang-joon, and Yeom Hye-jin from the Korea Institute of Science and Technology (KIST) announced on Wednesday that they have developed a home-use kit for the convenient diagnosis of bladder cancer.
Their newly developed bladder cancer diagnostic kit is evaluated as an innovative technology that enables the early diagnosis of bladder cancer using only a urine sample, without the need for invasive testing. The “BLOOM (Buoyancy-Lifted bio-interference Orthogonal Organogel Messenger) System” can detect bladder cancer biomarkers without the urine pretreatment.
The research team created a hydrogel film that can detect bladder cancer biomarkers through an enzyme reaction. They inserted a buoyancy-driven signal transmitter into the film, designed to generate signals only in the oil layer by separating the water and oil layers. This technology resolves the issue of impurities, such as hematuria, that interfere with the signal.
The research team stated that the kit can accurately diagnose even early-stage bladder cancer. The research team evaluated the diagnostic kit on 60 patients with bladder cancer, 20 patients with urological diseases, and 25 healthy individuals who received treatment at the Department of Urology at Korea University Anam Hospital.
The evaluation results showed that the BLOOM System achieved a sensitivity of 88.8 percent and a specificity of 88.9 percent, surpassing the sensitivity of 20 percent of existing commercial kits. In particular, it was able to diagnose early-stage bladder cancer, which was difficult to diagnose with existing diagnostic methods, with the same accuracy.
“In particular, it can be used with high accuracy while ensuring patient safety even in medical institutions with low invasive tissue examination skills or inadequate infrastructure,” Professor Kang said. “It will help improve the universal quality of medical care.”
Dr. Jeong said, “The BLOOM System is an innovative technology designed to accurately detect biomarkers while addressing issues such as blood in urine. It presents a new technical direction that overcomes the limitations of existing urine diagnostic methods and paves the way for further development.”
The research team’s findings were published in the July issue of the international academic journal Nature Biomedical Engineering (IF 27.7, JCR field 0.4%) as the cover article, titled “Diagnosis of early-stage bladder cancer via unprocessed urine samples at the point of care.”