Summary & Overview
CPT 0465U: UriFind methylation assay for bladder cancer risk
Headline: New CPT code 0465U identifies a proprietary methylation assay tied to bladder cancer risk
Lead: CPT code 0465U designates the UriFind® proprietary laboratory assay, a molecular test that detects methylation of the ONECUT2 and VIM DNA markers to stratify bladder cancer risk. The code matters nationally because it standardizes billing and reporting for a single-manufacturer diagnostic that can influence diagnostic pathways for patients evaluated for bladder cancer.
What the code represents and why it matters: CPT code 0465U applies exclusively to the UriFind® cancer assay from DiaCarta Inc. and AnchorDx. It captures a lab-performed molecular diagnostic that yields a binary result—positive or negative—based on methylation status of two markers associated with bladder cancer. Standardized coding supports claims processing, utilization tracking, and comparative evaluation of molecular diagnostics across payers.
Key payers covered: Analysis includes national payers: Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare.
What readers will learn: The publication provides clinical context for the assay, national payer coverage framing, coding and reporting considerations for a PLA code, and what to expect in terms of service setting and use cases. Data not available in the input is identified where applicable, and readers will find concise guidance on the code's scope and implications for laboratory billing and diagnostic workflows.
Billing Code Overview
CPT code 0465U is a Proprietary Laboratory Analyses (PLA) code reported only for the UriFind® cancer assay manufactured by DiaCarta Inc. and AnchorDx. The test analyzes a patient sample to detect DNA methylation changes in two specific markers, ONECUT2 and VIM, and reports a positive or negative result. A positive result indicates the presence of these methylation markers and suggests a high risk of bladder cancer.
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Service type: Molecular diagnostic laboratory test (proprietary methylation assay)
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Typical site of service: Clinical laboratory or specialty diagnostic laboratory processing patient specimens
Clinical & Coding Specifications
Clinical Context
A 65-year-old patient with a history of smoking presents to urology with intermittent painless hematuria and urinary frequency. The urologist collects a voided urine specimen or orders a urine-based molecular test to evaluate for bladder cancer. The clinician orders the UriFind® cancer assay (0465U) to detect methylation of ONECUT2 and VIM genes. The specimen is sent to DiaCarta Inc. or AnchorDx laboratory. The lab performs DNA extraction and methylation-specific analysis, then reports a binary result: positive (methylation detected; high risk for bladder cancer) or negative (methylation not detected; lower risk). Results are reviewed by the ordering urologist who integrates findings with cystoscopy, urine cytology, imaging, and clinical history to guide surveillance, diagnostic cystoscopy, biopsy, or continued monitoring.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | No modifier | Standard reporting when no modifier applies to the service |
26 |