Integrated Methylation and Copy Number Analysis for Noninvasive Bladder Cancer Detection in Urine.
A new urine test combining DNA and methylation analysis outperforms individual components, offering a practical home-based alternative to cystoscopy for bladder cancer surveillance.
Amsterdam UMC investigators developed iSECURE, requiring less input DNA than parallel assays by generating a single sequencing library used for both SCNA profiling (via tumor fraction estimation) and targeted methylation analysis of GALR1/HAND2/NRN1. In 89 subjects (30 primary BC, 28 recurrent BC, 31 hematuria controls) using home-collected urine and leave-one-out cross-validation, the integrated assay outperformed each component alone—establishing this as a clinically practical surveillance alternative to cystoscopy.
What the study was
- Study design
- prospective_diagnostic_cohort
- Population
- Bladder cancer patients and hematuria controls (home-collected urine)
- Sample size
- 89
- Category
- Early Detection
- Maturity
- Validated
- Journal
- JCO Precis Oncol
Why it surfaced
Single-workflow dual-modality cfDNA assay from home-collected urine addresses patient burden in bladder cancer surveillance; AUC 0.94 with LOOCV validation in a multi-stage cohort is strong; JCO Precis Oncol publication; direct clinical translation pathway visible.
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