Summary & Overview
CPT 0005U: ExosomeDx Prostate (IntelliScore) Urine Gene Expression Risk Test
CPT code 0005U designates the ExosomeDx® Prostate (IntelliScore), a Proprietary Laboratory Analyses (PLA) molecular diagnostic that measures expression of three genes in urine and applies an algorithm with patient data to produce a prostate cancer risk score. The code matters nationally because it represents a manufacturer-specific, lab-specific advanced diagnostic that can influence clinical decision-making around prostate cancer diagnosis and management, and it intersects with evolving coverage and coding practices for molecular and algorithmic tests. Key payers discussed include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise overview of clinical intent and service setting, plus benchmark and coverage considerations relevant to payer policies and billing practice for PLA codes. The publication summarizes payer coverage patterns, reimbursement benchmarks where available, and policy updates affecting use of proprietary molecular diagnostics. It also places the test in clinical context—urine-based gene expression profiling with algorithmic risk scoring for prostate cancer—and outlines operational implications for specimen collection and lab processing. Data not available in the input is identified where applicable.
Billing Code Overview
CPT code 0005U is a Proprietary Laboratory Analyses (PLA) code that describes the ExosomeDx® Prostate (IntelliScore) test from Exosome Diagnostics, Inc. The test performs gene expression profiling of three specific genes associated with prostate cancer on a urine specimen and uses algorithmic analysis combined with specific patient information to report a risk score that helps clinicians manage prostate cancer.
Service Type: Gene expression profiling / molecular diagnostic test with algorithmic risk scoring
Typical Site of Service: Clinical laboratory or certified diagnostic testing facility, with specimen collection typically performed in outpatient settings such as urology clinics or outpatient collection centers.
Clinical & Coding Specifications
Clinical Context
A typical patient is a man with an elevated prostate-specific antigen (PSA) level, atypical digital rectal exam (DRE), or prior negative prostate biopsy with ongoing clinical concern for clinically significant prostate cancer. The ordering clinician (urologist or primary care physician) collects a first-catch urine specimen after a standardized prostate massage or post-DRE urine collection and sends the specimen to the performing laboratory. The laboratory performs the ExosomeDx® Prostate (IntelliScore) gene expression assay (0005U), measuring expression of three prostate cancer–associated genes from urinary exosomes, integrates the laboratory results with specified clinical variables using the proprietary algorithm, and reports a risk score to assist the clinician in shared decision-making about the need for prostate biopsy, active surveillance, or other management. Typical site of service is an outpatient clinic, urology office, or independent clinical laboratory. Turnaround time and result interpretation are provided in the laboratory report; counseling and biopsy recommendations occur in subsequent clinic visits.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | Default, no modifier | Use when no specific modifier applies to the service |