New diagnostic device could enable at-home early bladder cancer detection

By Dr. Chinta SidharthanReviewed by Lily Ramsey, LLMJan 23 2025

Innovative diagnostic kit uses fluorescence-based detection to achieve 90% accuracy in identifying early-stage bladder cancer.

Study: Diagnosis of early-stage bladder cancer via unprocessed urine samples at the point of care. Image Credit: Orawan Pattarawimonchai/Shutterstock.com

In a recent study published in Nature Biomedical Engineering, a research team from the Republic of Korea explored a novel diagnostic system for detecting early-stage bladder cancer using unprocessed urine samples.

The study showed that the device uses a two-layer system and floating particles to send fluorescent signals, removing the need for sample preparation and making it a promising option for early detection of bladder cancer at home.

Background

Bladder cancer is one of the most globally prevalent forms of cancer and is characterized by high recurrence and progression rates. Early diagnosis, particularly during non-muscle-invasive stages, is crucial as it significantly improves survival outcomes.

However, current diagnostic methods, such as cystoscopy and urine cytology, are invasive, costly, and require specialized personnel. Moreover, these approaches often lack sensitivity for early detection and are often affected by the heterogeneity of urine samples.

Several non-invasive, urine-based diagnostic methods, including molecular and enzymatic assays, have emerged in recent times. However, these methods frequently require sample pre-treatment or fail to maintain accuracy in detecting biomarkers at low concentrations, especially in complex samples like those with hematuria.

This unmet need for a sensitive, specific, and user-friendly point-of-care diagnostic tool highlights the urgency to develop accessible systems for early bladder cancer detection and monitoring.

The current study

In the present study, the team developed and validated a diagnostic device using a biphasic system containing buoyant organogel particles, which are made by mixing low molecular weight compounds with organic media to detect early-stage bladder cancer from untreated urine samples.

They called the assay the buoyancy-lifted bio-interference-orthogonal organogel messenger or BLOOM.

The system involved the enzymatic degradation of hyaluronic acid-based bigel films containing organogel particles.

Upon degradation by urinary hyaluronidase, a biomarker for bladder cancer, the buoyant organogel particles would float to the oil layer, releasing solvatochromic fluorescent dyes. Solvatochromic dyes change color when dissolved in different solvents.

The preparation of the organogel involved emulsifying Nile red dye, oleic acid, and 12-hydroxystearic acid in toluene, followed by cooling to form uniform, self-floating particles.

These particles were incorporated into cross-linked hyaluronic acid hydrogels using glutaraldehyde. These bigel films were optimized for stability and sensitivity to low concentrations of hyaluronidase by adjusting the cross-linking density.

For the diagnostic application, the researchers added the untreated urine samples to the bigel-coated surface, followed by a dodecane oil layer to form the biphasic system. The fluorescence signal generated by the dissolved organogel in the oil phase was measured.

Furthermore, clinical validation of the device was conducted using 105 urine samples, including those from bladder cancer patients, individuals with other genitourinary conditions, and healthy controls.

The device was further tested using a low-cost, portable smartphone-based fluorescence reader. This minimized the need for laboratory infrastructure, enabling potential at-home use.

Results

The study demonstrated that the new diagnostic system effectively identified bladder cancer, including early-stage cases, with high sensitivity and specificity.

Using unprocessed urine samples, the system achieved an accuracy of approximately 90% in a clinical trial involving 105 participants, which included patients with bladder cancer, individuals with other genitourinary conditions, and healthy controls.

The device's ability to detect hyaluronidase activity, a key bladder cancer biomarker, was confirmed even in samples with complex compositions, such as those containing blood, from hematuria patients.

Additionally, the biphasic system proved to be stable at maintaining signal clarity by spatially separating the fluorescent signal from urine components that could interfere with detection.

Moreover, the analysis of the receiver operating characteristic curve indicated that the device exhibited strong diagnostic performance for early-stage cancers. Additionally, it reliably differentiated non-muscle-invasive bladder cancer (NMIBC) cases from healthy controls and other genitourinary conditions, which are commonly missed by existing diagnostic tools.

When compared with the NMP22 or Nuclear Matrix Protein 22 test approved by the Food and Drug Administration (FDA), the new system showed significantly higher sensitivity, especially for NMIBC and early-stage cases.

The device also overcame challenges posed by hematuria and provided accurate results regardless of the blood content in the samples.

Furthermore, the integration of a smartphone-based fluorescence reader further validated the system's practicality, enabling low-cost, consistent, and user-friendly testing.

These findings suggested that the BLOOM system is a promising tool for non-invasive, at-home bladder cancer screening and early detection and could address the critical gaps in existing diagnostic approaches.

Conclusions

To summarize, the research team developed a sensitive, specific, and user-friendly diagnostic tool for bladder cancer, enabling early detection using unprocessed urine samples.

The biphasic system, combined with a smartphone-based fluorescence reader, offers an accessible and affordable solution for at-home testing.

Furthermore, by addressing the limitations of existing methods, such as interference from hematuria and low biomarker sensitivity, this innovation represents a significant advancement in non-invasive cancer diagnostics.