Diagnosis of early-stage bladder cancer via unprocessed urine samples at the point of care.

Diagnostic kits for the optical detection of bladder cancer in urine can facilitate effective screening and surveillance. However, the heterogeneity of urine samples, owing to patients with bladder cancer often presenting with haematuria, interfere with the transduction of the optical signal.

Here we describe the development and point-of-care performance of a device for the detection of bladder cancer that obviates the need for sample processing. The device leverages the enzymatic release of organogel particles carrying solvatochromic fluorophores in the presence of urinary hyaluronidases-a bladder cancer biomarker. Owing to buoyancy, the particles transfer from the urine sample into the organic phase, where the change in fluorescence can be measured via a smartphone without interference from blood proteins. In a double-blind study with 80 unprocessed urine samples from patients with bladder cancer (including samples with haematuria) or other genitourinary diseases and with 25 samples from healthy participants, our system distinguished the cancerous samples, including those with early-stage bladder cancer, with accuracies of about 90%. Obviating the need for sample pretreatment may facilitate the at-home detection of bladder cancer.

Nature biomedical engineering. 2024 Nov 28 [Epub ahead of print]

Changjoon Keum, Haejin Yeom, Tae Il Noh, Seung Yong Yi, Soyeong Jin, Chaekyu Kim, Ji Sung Shim, Sung Goo Yoon, Hojun Kim, Kwan Hyi Lee, Seok Ho Kang, Youngdo Jeong

Center for Advanced Biomolecular Recognition, Biomedical Research Division, Korea Institute of Science and Technology (KIST), Seoul, Republic of Korea., Department of Urology, Korea University School of Medicine, Seoul, Republic of Korea., Fusion Biotechnology, Inc., Ulsan, Republic of Korea., Center for Advanced Biomolecular Recognition, Biomedical Research Division, Korea Institute of Science and Technology (KIST), Seoul, Republic of Korea. ., Department of Urology, Korea University School of Medicine, Seoul, Republic of Korea. ., Center for Advanced Biomolecular Recognition, Biomedical Research Division, Korea Institute of Science and Technology (KIST), Seoul, Republic of Korea. .

Read an Expert Commentary by Bishoy Faltas, MD