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    v1.0.30
    OpenPayerBilling CodesProprietary Laboratory AnalysesCPT cpt-0391u-strata-select-ngs-437-gene-tumor-profiling
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    CPT 0391U: Strata Select™ NGS Tumor DNA/RNA Panel

    CPT code 0391U is a Proprietary Laboratory Analyses (PLA) code for the Strata Select™ test from Strata Oncology Inc., a next-generation sequencing (NGS) assay performed on formalin-fixed paraffin-embedded (FFPE) solid tumor tissue to analyze DNA and RNA across 437 genes and evaluate findings to guide potential immunotherapy treatment options; service type: NGS tumor profiling and genomic analysis; typical site of service: outpatient or hospital-based clinical laboratory or molecular pathology laboratory processing FFPE tumor specimens.

    For related coverage guidance, see recent payer policy updates: Prenatal (Fetal) Diagnostic Testing, Oral Cancer Screening and Testing, RTM Testing for Alpha-1 Antitrypsin Deficiency.

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    Clinical & Coding Specifications

    Clinical Context

    A patient with a newly diagnosed or recurrent solid tumor undergoes tumor profiling to guide systemic therapy selection. The oncologist orders Strata Select™ next-generation sequencing (NGS) on formalin–fixed paraffin–embedded (FFPE) tumor tissue to evaluate DNA and RNA from 437 cancer-related genes and identify alterations relevant to targeted therapy and immunotherapy. Typical workflow: tumor tissue (biopsy or resection specimen) is collected in the surgical or interventional radiology suite and processed by the pathology laboratory; a pathologist reviews cellularity and tumor content, prepares FFPE blocks or unstained slides, and sends the material to Strata Oncology for testing. Results are returned as a report summarizing somatic variants, gene fusions, tumor mutational burden, and actionable findings that inform immunotherapy options and targeted treatment selection. The service is billed by the performing laboratory using the Proprietary Laboratory Analysis code 0391U and is commonly provided in an outpatient oncology clinic, hospital pathology lab, or reference laboratory setting.

    Related CPT Codes

    CPT CodeDescriptionRelationship to This Procedure
    88305Level IV surgical pathology, gross and microscopic examinationPerformed by pathology to evaluate tumor tissue and determine suitability for NGS testing prior to dispatching FFPE material.
    88342Immunohistochemistry, each antibody (List separately in addition to code for primary tissue exam)May be performed to characterize tumor subtype and complement molecular results when guiding immunotherapy decisions.
    88172Cytopathology, cell block preparationUsed when cell block material from fine needle aspiration is prepared as FFPE for molecular testing.
    81445Oncology (somatic) gene analysis by NGS, identification of variants, hot spot analysis (example)Other NGS-based molecular codes that may be used for alternative or supplementary tumor profiling; relates conceptually to comprehensive genomic profiling performed by 0391U.
    99000Handling and/or special delivery (example non-covered)Administrative or specimen handling charges that may accompany sending specimens to an external reference lab.

    Note: If payers require separate reporting of technical and professional components or additional pathology services, those codes may appear in the same clinical workflow surrounding the proprietary PLA report 0391U.

    Related Modifiers

    6 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…
    90Modifier ‑90 (Reference/Outside Laboratory) indicates that a laboratory test was performed by an entity other than the treating or reporting provider. The American Medical Association defines…- Use CPT modifier -90 when a laboratory test is performed by an outside/reference laboratory (an entity other than the treating or reporting physician or qualified professional) and the claim needs…
    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…
    76Modifier -76, Repeat Procedure or Service by Same Physician or Other Qualified Health Care Professional, is appended when the same provider performs an identical, medically necessary procedure or…- Use modifier -76 when the same physician or other qualified health care professional performs an identical procedure or service a second (or subsequent) time on the same date of service and the…
    77Modifier 77 indicates that a previously performed procedure or service was legitimately repeated by a different physician or other qualified health care professional. The AMA’s CPT definition…- Use modifier 77 when a basic procedure or service already performed is repeated by a different physician or other qualified health care professional (for example, a second provider independently…

    Related Provider Taxonomies

    8 rows

    Taxonomy Code
    208000000X
    207Q00000X
    2086S0122X
    363L00000X
    2084N0400X
    341600000X
    207SG0201X
    261QB0400X

    Related Payer Policy Updates

    Specialty: Genetic & Molecular Testing1 / 3

    10 rows

    PolicyPayerEffective Date
    Prenatal (Fetal) Diagnostic TestingBlue Cross Blue Shield - Rhode Island2027-01-01
    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
    Polygenic Risk ScoreBlue Cross Blue Shield - Rhode Island2026-12-01
    Gene Expression Profiling for Cutaneous MelanomaBlue Cross Blue Shield - Rhode Island2026-12-01
    Genetic Testing for Diagnosis and Management of Mental Health ConditionsBlue Cross Blue Shield - Rhode Island2026-11-01
    Molecular Testing in the Management of Pulmonary NodulesBlue Cross Blue Shield - Rhode Island2026-11-01
    Genetic Testing for Hereditary Cancer (for North Carolina Only)Colorado Rocky Mountain Health Plans2026-10-01
    Expanded Molecular Testing of Cancers to Select Targeted TherapiesBlue Cross Blue Shield - North Dakota2026-10-01

    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-0005U-PROSTATE-EXOSOMEDX-INTELLISCORE-GENE-EXPRESSION-URINE-TEST

    CPT 0005U: ExosomeDx Prostate (IntelliScore) urine gene expression test

    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

    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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