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. |