March 18, 2025 | The incidence of bladder cancer is rising significantly due to population aging and, while survival rates are relatively high, when diagnosed late patients may need to undergo bladder removal regardless of survival. Early detection and treatment of bladder cancer are therefore crucial to preserving the organ and maintaining the patient’s quality of life, according to Youngdo Jeong, Ph.D., principal research scientist with the Center for Advanced Biomolecular Recognition at the Korea Institute of Science and Technology.
Bladder removal is the standard treatment for muscle-invasive bladder cancer, an advanced stage of the disease, he points out. This is an eight-to-10-hour operation with an 80% complication rate, followed by either the construction of a neobladder or the use of an external urine collection bag.
Many research teams and companies are looking to develop a non-invasive urine-based diagnostic tool for bladder cancer in recognition of the clinical need, he says. For his part, Jeong is leading research efforts to develop a simple and affordable yet accurate home urine test kit that in clinical trials achieved a sensitivity of 88.8%—heads above the 20% seen with existing commercialized urine-based diagnostic kits —and, notably, demonstrated its ability to detect early-stage cases, as reported recently in Nature Biomedical Engineering (DOI: 10.1038/s41551-024-01298-0).
The current dilemma is that both standard diagnostic methods are ill-suited for early detection where frequent and regular testing is the best approach. Urine cytology has low sensitivity (subjective reading with 12% to 48% accuracy) while cystoscopy, despite being highly sensitive and accurate, is highly invasive and comes with a risk of infection, explains Jeong.
“Laboratory-based diagnostic kits utilizing gene biomarkers with amplification techniques have been developed to improve sensitivity... particularly for early-stage bladder cancer, where bladder preservation is still possible,” he continues. “However, these tests require sample transportation, specialized diagnostic protocols, trained professionals, and laboratory facilities, making them expensive.”
With the BLOOM assay of Jeong and his team, “patients can perform the test themselves by adding urine to a provided container, introducing a layer of oil, and waiting for a signal to appear in the oil layer,” he says. Critically, the method has sensitivity comparable to laboratory-based tests.
A key component of the BLOOM diagnostic kit is a hydrogel film that encapsulates a “buoyant signal carrier” inside, Jeong says. The urine of bladder cancer patients has specific enzymes capable of breaking down this hydrogel and, once it is degraded, the signal carrier gets released.
Because of its buoyancy, “the signal carrier rises through the urine and reaches the oil layer,” he says. Here, “it undergoes a phase transition and disintegrates, releasing the signaling molecules that generate a detectable signal within the oil layer.”
The rationale for this complex design is twofold, Jeong says. First, about 85% of bladder cancer patients experience hematuria, or blood in the urine, which can “interfere with detection by either generating false signals in the urine or affecting the accuracy of the actual signal.” Second, “urine contains numerous impurities besides biomarkers” and they can “biochemically alter or interfere with signal conversion, leading to diagnostic errors.”
Since “buoyancy operates as a purely physical force,” it is resistant to direct interference from both urine impurities and hematuria, he says. “Just as a floating tube remains buoyant in both clean and contaminated water, the buoyant signal carrier moves to the oil layer regardless of the impurities present in the urine,” thereby minimizing the impact of urine contaminants on diagnostic accuracy.
Signal amplification is the other “crucial principle” of the BLOOM system, adds Jeong. Although the concentration of biomarkers in urine is generally very low, the device utilizes enzymes as biomarkers to “catalyze repeated reactions, leading to an initial amplification of the signal.
“Furthermore, the buoyant signal carriers released by the enzymatic reaction undergo a second amplification as they rise to the oil layer and release their signal,” he continues. “While amplification typically increases background noise and errors, our dual-layer design and buoyant signal carrier system effectively mitigate these issues, allowing for a highly amplified signal while maintaining high diagnostic accuracy.”
Admittedly, Jeong says, the impressive 88.8% detection capability of BLOOM was demonstrated on a cohort of 80 bladder cancer patients in Korea and 25 healthy individuals who had no known urological diseases within the past three years. Parallel testing of the new kit was done alongside existing commercial diagnostic tests to enhance credibility of the findings.
Expansion of the cohort could potentially yield “slightly” better or lower results, he says. “However, since our findings are based on a double-blind study with over 100 participants, we do not expect significant deviations from the reported results.”
In the latest study, it is noteworthy that a relatively high proportion of patients in the BLOOM cohort had early-stage bladder cancer (non-muscle-invasive bladder cancer), adds Jeong. Diagnostic performance of the device, as measured by the area under the curve (AUC) for all bladder cancer patients, was 0.93—and similar performance (AUC of 0.92) was seen with the early-stage bladder cancer patients.
“One key advantage of our system is that it does not rely on expensive materials such as antibodies or enzymes, making production more cost-effective,” Jeong says. Being a self-administered test, further cost reductions will come from eliminating the need for trained professionals, sample transportation, and laboratory facilities. “We also anticipate that hospitals and screening centers will be able to offer this test using simple diagnostic equipment at an affordable price,” he adds.
Before the end of this year, a startup called FloatBioscience is expected to launch to further develop and commercialize the technology, Jeong reports. “As we move forward with large-scale manufacturing and broader clinical trials, we expect to obtain statistically robust data that will enable more precise predictions regarding the test’s real-world impact.”
Researchers are now in the process of securing initial investors to establish the company, he says. In the meantime, they are developing automated production technologies to enable large-scale and standardized manufacturing of the test kits.
“Since this is a cancer diagnostic tool, the potential consequences of inaccurate results can be significant,” he notes. “As a result, regulatory approval requirements in South Korea are quite stringent. To obtain the necessary approvals for both manufacturing and commercial distribution, large-scale clinical trials will be essential. Our founding team is actively assembling talent and gathering the necessary data to meet these regulatory requirements.”
The goal is to bring the product to market within the next three to five years, with an initial launch in South Korea being followed by expansion into the U.S. and Europe. Additional investors will be sought to support international expansion and regulatory approvals in those markets once mass production capabilities are fully established, says Jeong.
The underlying technology could be used for the early detection of other diseases beyond bladder cancer. Jeong and his team are currently developing hydrogel films tailored for detecting other urological cancers, such as prostate and kidney cancer.
Recent studies have identified enzyme biomarkers specific to pancreatic cancer, so they will also be expanding the BLOOM system to detect these biomarkers in blood samples to enable early detection of pancreatic cancer. Jeong says he would love to connect and explore new diagnostic possibilities with other researchers or clinicians who see opportunities for collaboration.