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    v1.0.30
    OpenPayerBilling CodesProprietary Laboratory AnalysesCPT cpt-0005u-prostate-exosomedx-intelliscore-gene-expression-urine-test
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    CPT 0005U: ExosomeDx Prostate (IntelliScore) urine gene expression test

    CPT code 0005U describes the ExosomeDx® Prostate (IntelliScore), a Proprietary Laboratory Analyses (PLA) test that performs gene expression profiling of three prostate cancer–associated genes on a urine specimen and uses an algorithm combining test results with patient information to generate a risk score to help clinicians manage prostate cancer; service type: molecular diagnostic/clinical laboratory testing with algorithmic risk reporting; typical site of service: outpatient laboratory or clinician-ordered diagnostic testing on a urine specimen.

    For related coverage guidance, see recent payer policy updates: Oral Cancer Screening and Testing, RTM Testing for Alpha-1 Antitrypsin Deficiency, Cytochrome P450 Genotype-Guided Treatment Strategy Corporate Medical Policy.

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    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.

    Related CPT Codes

    CPT CodeDescriptionRelationship to This Procedure
    0005UExosomeDx® Prostate (IntelliScore) — gene expression profiling panel on urine with algorithmic analysis reporting a risk scorePrimary Proprietary Laboratory Analysis (PLA) code describing the assay performed on the urine specimen and reported to guide prostate cancer management
    80053Comprehensive metabolic panelCommonly ordered at baseline to assess general health and pre-procedural risk when planning biopsy
    84153Prostate specific antigen (PSA); totalOften ordered before or alongside this assay as the initial screening marker prompting further risk stratification
    76872Transrectal ultrasound, prostate, with biopsy guidancePerformed when the risk score and clinical evaluation indicate the need for prostate biopsy
    88305Level IV surgical pathology, gross and microscopic examinationUsed for pathologic examination of prostate biopsy specimens obtained after risk stratification

    Related Modifiers

    5 rows

    ModifierDescriptionWhen to Use
    26Modifier 26 (Professional Component) identifies and bills only the professional portion of a split service — the physician’s interpretation, report, and medical judgment — when the technical…- Use CPT Modifier -26 when you are billing only the professional component (PC) of a split‑bill eligible service—i.e., you performed the physician interpretation, medical judgment and prepared a…
    52Modifier ‑52 (Reduced Services) indicates that a service or procedure was partially reduced or omitted at the provider’s discretion, allowing reporting of the basic procedure number with a qualifier…- Use modifier -52 when a physician or qualified health professional electively reduces or omits part of a procedure or service (for example, performing fewer required views or omitting a portion of…
    53Modifier 53 (Discontinued Procedure) signals that a surgical or diagnostic service was begun by the physician but terminated because of extenuating circumstances that threatened the patient’s…- Use modifier -53 when a physician/qualified healthcare professional has started a surgical or diagnostic procedure (e.g., anesthesia administered, incision or scope insertion) and then discontinues…
    80CPT® Modifier 80 (Assistant Surgeon) is appended to a surgical CPT code when a physician (MD or DO) provides full, continuous assistance throughout the operative procedure. It is intended only for…- Use CPT Modifier -80 when a physician (MD or DO) serves as an assistant surgeon and provides full, continuous assistance throughout the entire operative procedure; append -80 to the surgical CPT…
    82Modifier 82 is appended to a surgical CPT code to indicate that an attending physician acted as an assistant because a qualified resident surgeon was unavailable. In teaching hospitals it documents…- When to use: Append modifier 82 in teaching-hospital settings to indicate a physician served as an assistant surgeon because a qualified resident surgeon was unavailable (includes situations where…

    Related Provider Taxonomies

    8 rows

    Taxonomy Code
    208D00000X
    207Q00000X
    246RP1900X
    163WN0800X
    2471S1302X
    310400000X
    2083P0500X
    3336S0011X

    Related Payer Policy Updates

    Specialty: Genetic & Molecular Testing1 / 3

    10 rows

    PolicyPayerEffective Date
    Oral Cancer Screening and TestingOscar Health2027-01-01
    RTM Testing for Alpha-1 Antitrypsin DeficiencyOscar Health2027-01-01
    Cytochrome P450 Genotype-Guided Treatment Strategy Corporate Medical Policybcbsvermont2027-01-01
    Carrier Testing Panels for Genetic Diseases (for Kentucky Only)UnitedHealthcare2026-10-01
    Genetic Testing for Neurological Disorders (for Kansas Only)UnitedHealthcare2026-10-01
    Genetic and Molecular TestingProvidence Health Plan2026-10-01
    Cell-Free Fetal DNA Testing (for Idaho Only)UnitedHealthcare2026-10-01
    Next Generation Sequencing for Minimal Residual Disease DetectionProvidence Health Plan2026-10-01
    Pharmacogenetic Panel Testing (for Kansas Only)UnitedHealthcare2026-10-01
    Non-Covered Genetic Panel TestsProvidence Health Plan2026-10-01

    Related Codes

    CPT-0001U-PRECISETYPE-HEA-MULTIPLEX-RBC-ANTIGEN-GENOTYPING

    CPT 0001U: PreciseType HEA Erythrocyte Antigen Genotyping

    CPT-0002U-POLYPDX-URINE-METABOLOMIC-ASSAY-ADENOMATOUS-POLYP-RISK

    CPT 0002U: PolypDX™ Urine Metabolomic Risk Assay

    CPT-0003U-OVAR-A-NEXT-GENERATION-OVARIAN-CANCER-RISK-ASSAY

    CPT 0003U: Overa (MIA2G) Ovarian Cancer Risk Assay

    CPT-0007U-TOXPROTECT-URINE-DRUG-SCREEN-WITH-DNA-AUTHENTICATION

    CPT 0007U: ToxProtect Urine Drug Screen With DNA Authentication

    CPT-0008U-H-PYLORI-ANTIBIOTIC-RESISTANCE-SEQUENCING-PANEL

    CPT 0008U: H. pylori Antibiotic Resistance Gene Panel

    CPT-0009U-DEPARRAY-HER2-FISH-TUMOR-CELL-ISOLATION

    CPT 0009U: DEPArray HER2 Tumor‑Cell Isolation with FISH Analysis

    CPT-0010U-BACTERIAL-TYPING-WHOLE-GENOME-SEQUENCING-MAYO-CLINIC

    CPT 0010U: Bacterial Typing by Whole Genome Sequencing, Mayo Clinic

    CPT-0011U-CORDANT-CORE-ALGORITHMIC-ORAL-FLUID-DRUG-TEST

    CPT 0011U: Oral Fluid Drug Test with Algorithmic Steady‑State Comparison

    CPT-0016U-BCR-ABL1-MAJOR-MINOR-FUSION-TRANSCRIPT-TESTING

    CPT 0016U: BCR–ABL1 Major and Minor Breakpoint Fusion Transcripts

    CPT-0017U-JAK2-MUTATION-UNIVERSITY-OF-IOWA

    CPT 0017U: JAK2 Mutation Sequencing, University of Iowa

    Showing 1–10 of 536

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    Frequently Asked Questions

    References

    1. 1.CPT® Codes and Descriptions. AAPC. Retrieved Aug 11, 2026.Maintains the CPT code set's official descriptions and guidelines, licensed from the American Medical Association, used as the definitional source for CPT codes on this page.
    2. 2.HCPCS Quarterly Update. Centers for Medicare & Medicaid Services (CMS). Retrieved Aug 11, 2026.CMS's quarterly release of HCPCS Level II codes and short/long descriptors, the source for HCPCS code definitions and update history.
    3. 3.ICD-10-CM Full Code List. Centers for Medicare & Medicaid Services (CMS). Retrieved Aug 11, 2026.CMS's complete ICD-10-CM diagnosis code list, used to cross-reference diagnosis codes associated with this procedure or service.
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