Summary & Overview
CPT 0250U: PGDx elio tissue complete NGS Tumor Genomic Profiling
CPT code 0250U designates a Proprietary Laboratory Analyses (PLA) test — PGDx elioTM tissue complete from Personal Genome Diagnostics Inc. — that uses next-generation sequencing (NGS) to profile formalin–fixed paraffin–embedded (FFPE) solid tumor tissue across 505+ genes for somatic mutations, indels, SNVs, and translocations. This high-complexity genomic assay supports personalized oncology care by identifying actionable variants that can inform targeted therapies and clinical trial eligibility, making it a nationally relevant code as precision oncology grows.
Key payers covered in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise overview of the code’s clinical purpose, typical site and service type, and the payer landscape addressed in the analysis. The publication provides benchmarks and coverage context, outlines common billing modifiers and operational considerations, and summarizes clinical context for use in solid tumor management. Data not available in the input includes associated taxonomies, specific ICD-10 diagnoses, related billing codes, and service line detail.
Billing Code Overview
CPT code 0250U is a Proprietary Laboratory Analyses (PLA) code for PGDx elioTM tissue complete, a next-generation sequencing (NGS) assay from Personal Genome Diagnostics Inc. The test evaluates formalin–fixed paraffin–embedded (FFPE) solid tumor tissue across more than 505 genes to detect somatic mutations, including insertions and deletions (indels), single nucleotide variants (SNVs), and translocations, to guide treatment decisions across a broad range of solid tumor types and organ systems.
Service type: Comprehensive tumor genomic profiling using NGS
Typical site of service: Clinical laboratory performing NGS on FFPE solid tumor tissue
Clinical & Coding Specifications
Clinical Context
A 62-year-old patient with a history of metastatic non-small cell lung cancer (NSCLC) presents after progression on first-line therapy. A recent tumor biopsy of a lung mass was formalin-fixed and paraffin-embedded (FFPE). The oncology team requests comprehensive genomic profiling to identify actionable somatic alterations across a broad panel of cancer genes to guide subsequent targeted therapy and immunotherapy decisions. Tissue is forwarded to the molecular pathology laboratory performing NGS-based testing.
The laboratory performs the PGDx elioTM tissue complete assay (0250U), a Proprietary Laboratory Analysis that sequences >505 cancer-associated genes from FFPE tumor tissue to detect single nucleotide variants (SNVs), insertions and deletions (indels), copy-number alterations, and structural rearrangements (translocations). A pathology review confirms tumor content and suitability for testing, DNA/RNA extraction is completed, library preparation and sequencing are performed, bioinformatics pipelines analyze variants, and a clinical report is issued to the treating oncologist describing detected alterations and their potential therapeutic relevance. Typical sites of service include hospital outpatient laboratories, independent molecular pathology laboratories, and specialized commercial reference labs. The service type is high-complexity molecular diagnostic testing (next-generation sequencing), billed as a PLA test specific to Personal Genome Diagnostics Inc.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 |