Summary & Overview
CPT 0391U: Strata Select™ NGS Tumor Profiling, 437-Gene DNA/RNA Panel
CPT code 0391U designates Strata Select™, a proprietary next-generation sequencing (NGS) assay from Strata Oncology Inc. that performs combined DNA and RNA analysis of 437 genes on FFPE solid tumor tissue to identify variants and biomarkers that may inform immunotherapy options. As a PLA code, 0391U is specific to a single manufacturer's test, which affects billing, coverage determinations, and clinical reporting workflows nationwide.
Key payers discussed include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. The publication provides a national perspective on clinical context, common coverage approaches, and typical claim handling considerations for high-complexity NGS tumor profiling. Readers will find benchmark-oriented insights into where 0391U sits within molecular oncology testing, an explanation of service type and typical sites of service, and a summary of common modifiers used in claims when applicable. The report highlights implications of PLA coding for payer policy, coding specificity, and downstream utilization of results in oncology care pathways.
This summary is intended to orient clinical, coding, and policy audiences to the purpose and scope of CPT code 0391U and what to expect from payer interactions and clinical reporting related to Strata Select™ NGS tumor profiling.
Billing Code Overview
CPT code 0391U is a Proprietary Laboratory Analyses (PLA) code that applies exclusively to the Strata Select™ test from Strata Oncology Inc. The assay uses next-generation sequencing (NGS) to analyze formalin-fixed paraffin-embedded (FFPE) solid tumor tissue for DNA and RNA across 437 genes and interprets findings to guide potential immunotherapy treatment options.
Service type: Laboratory — NGS-based tumor profiling (DNA/RNA) for solid tumor specimens
Typical site of service: Clinical laboratory or reference laboratory processing FFPE tumor tissue; specimen collection typically from outpatient or inpatient oncology settings
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.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
26 | Professional component | Use when billing only the professional interpretation component if separated from the technical component. |
TC | Technical component | Use when billing only the technical component (laboratory processing and reporting) if separated from the professional component. |
90 | Reference (outside) laboratory | Data not provided in input. |
QK | Medical direction of two, three, or four technicians | Use when the submitting laboratory documents medical direction of multiple qualified personnel (if applicable per insurer rules). |
QX | CLIA waiver certification of a non-physician practitioner | Use when applicable to non-physician practitioner ordering or supervising components per payer rules (rare for PLA tests). |
QY | Medical direction of one certified laboratory technician | Use when documentation supports medical direction of a single technician under applicable rules. |
52 | Reduced services | Use when the test is partially performed or limited by specimen adequacy and a reduced service is reported. |
53 | Discontinued procedure | Use if testing was started but discontinued for unforeseen clinical reasons and documentation supports it. |
76 | Repeat procedure by same physician or other qualified health care professional | Data not provided in input. |
77 | Repeat procedure by another physician or other qualified health care professional | Data not provided in input. |
| Taxonomy Code | Specialty | Notes |
|---|---|---|
208000000X | Anatomic Pathology | Pathologists review specimen adequacy and authorize molecular testing. |
207Q00000X | Medical Oncology | Oncologists order the test to guide systemic therapy selection. |
2086S0122X | Molecular Genetic Pathology | Specialists overseeing NGS assay selection and interpretation. |
363L00000X | Clinical Laboratory | Laboratory directors and managers responsible for technical processing and CLIA compliance. |
2084N0400X | Hematology & Oncology | Hematologist-oncologists who may order testing for solid tumor patients. |
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
C50.911 | Malignant neoplasm of unspecified site of right female breast | Breast cancers often undergo NGS profiling to identify actionable mutations and guide immunotherapy. |
C34.90 | Malignant neoplasm of unspecified part of unspecified bronchus or lung | Lung cancers frequently receive comprehensive genomic profiling for targeted and immunotherapy options. |
C61 | Malignant neoplasm of prostate | Advanced or recurrent prostate cancers may be profiled for actionable alterations. |
C18.9 | Malignant neoplasm of colon, unspecified | Colorectal cancers are evaluated for mutations and biomarkers relevant to immunotherapy decisions. |
C71.9 | Malignant neoplasm of brain, unspecified | Central nervous system tumors may be analyzed with NGS for targeted therapy trials and options. |
C83.90 | Non-Hodgkin lymphoma, unspecified, unspecified site | Selected hematologic malignancies may be included when FFPE solid tumor-like specimens are processed for molecular profiling. |
D49.1 | Neoplasm of uncertain behavior of lymphoid, hematopoietic and related tissue | When diagnostic uncertainty exists, molecular profiling can inform diagnosis and treatment planning. |
C80.1 | Malignant (primary) neoplasm, unspecified | Used when the primary site is not specified and comprehensive profiling is indicated to guide therapy. |
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
88305 | Level IV surgical pathology, gross and microscopic examination | Performed by pathology to evaluate tumor tissue and determine suitability for NGS testing prior to dispatching FFPE material. |
88342 | Immunohistochemistry, 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. |
88172 | Cytopathology, cell block preparation | Used when cell block material from fine needle aspiration is prepared as FFPE for molecular testing. |
81445 | Oncology (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. |
99000 | Handling 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.