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The Essence of Fluorescence
An at-home test kit, using fluorescence-based detection, identifies early-stage bladder cancer in unprocessed urine with 90 percent accuracy, according to a study published in Nature Biomedical Engineering.
The device, developed by a team in the Republic of Korea, detects bladder cancer biomarkers called urinary hyaluronidases as they pass through an organogel, causing enzymatic release of solvatochromic fluorophores. The change in fluorescence in the sample can then be detected via a smartphone app.
Because the biomarker particles are absorbed into the organic phase, there is no interference from blood proteins in the sample – overcoming a major limitation of most urine tests for early bladder cancer. This feature allows urine samples to be tested with no pretreatment.
The validation study tested urine samples from 105 participants – including patients with bladder cancer, other genitourinary conditions, and healthy volunteers. The system distinguished the cancerous samples, including those with early-stage bladder cancer, with 90 percent accuracy. By addressing the limitations of existing methods, such as low biomarker sensitivity and interference from hematuria, this innovation may facilitate non-invasive cancer diagnostics at the point of care.
Take Urine, Add AI
A new AI-powered urine test for the detection of bladder cancer has been granted FDA breakthrough device designation.
The assay analyzes the molecular signatures of volatile organic compounds (VOCs) in urine via gas chromatography mass spectrometry, then applies an AI algorithm to determine a cancer risk score. Its design was inspired by a dog’s ability to detect illness by sensing VOCs that the body releases when disease is present.
By assessing real-time changes in physiology and metabolism, the device has the potential to identify early patterns of disease before symptoms appear. It could reduce the number of costly and invasive cystoscopy examinations, which are routinely used to confirm or monitor bladder cancer. Sensitive enough to detect early-stage disease, it could help more patients receive treatment early, improving both outcomes and health economics for the disease.
FDA breakthrough device designation entitles developers to fast-tracked approval reviews. In this case, the designation recognizes the potential to provide an accessible, non-invasive method of early cancer detection. The bladder cancer assay will now undergo rigorous validation testing to support its approval application.
Liquid Biopsy Feasibility Boost
Researchers from Weill Cornell Medicine and the New York Genome Center have developed a highly sensitive, error-corrected whole-genome sequencing method that enables the detection of trace amounts of tumor DNA in blood samples.
Leveraging a low-cost sequencing platform, the team achieved ultra-deep sequencing coverage, allowing them to identify circulating tumor DNA (ctDNA) at concentrations as low as parts per million. In their study, the researchers demonstrated that this approach – enhanced with a built-in error-correction method – accurately detects ctDNA without requiring prior access to tumor tissue. Their proof-of-concept involved patients with bladder cancer and melanoma, where mutational signatures previously studied by collaborating labs were incorporated to improve sensitivity. This allowed the detection of changes in ctDNA levels corresponding to cancer progression or therapeutic response.
As costs decrease and sensitivity improves, this study substantiates the promise of next-generation sequencing in clinical oncology. The findings point to a future in which routine blood tests could provide a noninvasive alternative to tissue biopsies for ongoing cancer monitoring.
Urothelial Methylation Marker
A prospective study conducted by researchers at Asan Medical Center evaluated the diagnostic utility of a urinary PENK methylation test in detecting urothelial carcinoma, including bladder cancer and upper tract urothelial carcinoma (UTUC). The study enrolled 183 patients with 13 cancer types and assessed the test's sensitivity and specificity in distinguishing urothelial cancers from others. The test demonstrated a high overall sensitivity of 94 percent – 88 percent for bladder cancer and 100 percent for UTUC – and a specificity of 96 percent, supporting its promise as a noninvasive diagnostic biomarker for urothelial malignancies.
While most non-urothelial cases tested negative, a few positive results were observed in cervical, colorectal, liver, esophageal, and kidney cancers. These findings suggest that although PENK methylation is strongly associated with urothelial carcinoma, background methylation in other cancers or benign conditions may contribute to occasional false positives. Nonetheless, the methylation signal was significantly stronger in patients with confirmed urothelial carcinoma, reinforcing its diagnostic relevance.
The authors note that the test could complement or reduce reliance on invasive procedures such as cystoscopy and ureteroscopy, which are currently standard for bladder and UTUC diagnosis. Given its noninvasive nature and diagnostic accuracy, the PENK methylation assay shows promise for use in screening and surveillance, particularly for UTUC, where diagnostic tools are limited.
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