Summary & Overview
CPT 0543U: TruSight Oncology Comprehensive Tumor Genomic Profiling
CPT code 0543U represents a Proprietary Laboratory Analyses (PLA) code for the TruSight™ Oncology Comprehensive test from Illumina Inc., a next-generation sequencing assay that profiles DNA and RNA from tumor tissue across 517 cancer-associated genes. Nationally, this code signals growing use of comprehensive genomic profiling to inform targeted therapy selection, eligibility for clinical trials, and assessment of tumor mutation burden. Key payers in the analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare.
Readers will find a concise overview of what CPT code 0543U covers, the clinical and laboratory context for its use, and how it fits into molecular oncology testing workflows. The publication summarizes payer coverage patterns and benchmarking where available, highlights policy considerations relevant to PLA codes, and outlines clinical implications such as mutation detection scope and tumor mutation burden reporting. Data not available in the input for specific modifiers, taxonomies, ICD-10 pairings, and detailed payer policy language is noted as unavailable. This national-focused briefing is designed to inform billing, coding, and policy stakeholders about the technical scope and policy relevance of CPT code 0543U.
Billing Code Overview
CPT code 0543U is a Proprietary Laboratory Analyses (PLA) code that applies exclusively to the TruSight™ Oncology Comprehensive test from Illumina Inc. The assay analyzes DNA from tumor tissue to detect genetic alterations across 517 cancer-associated genes using next-generation sequencing. It detects single- and multi-nucleotide variants, insertions and deletions, and reports gene fusions and splice variants by incorporating RNA analysis. The test also calculates tumor mutation burden, which can inform understanding of tumor behavior and potential response to therapies.
Service type: Laboratory molecular diagnostic test (next-generation sequencing, tumor genomic profiling)
Typical site of service: Clinical or reference laboratory with specimens submitted from oncology clinics, hospital outpatient departments, or pathology services
Clinical & Coding Specifications
Clinical Context
A 62-year-old patient with a newly diagnosed metastatic non-small cell lung carcinoma (NSCLC) undergoes tumor biopsy. The oncology team requests comprehensive genomic profiling to identify actionable somatic alterations for targeted therapy selection and clinical trial eligibility. A formal pathology specimen (formalin-fixed, paraffin-embedded tumor tissue) is sent to the laboratory performing TruSight™ Oncology Comprehensive. The lab performs next-generation sequencing of tumor DNA and RNA to detect single-nucleotide variants, insertions/deletions, copy-number changes, gene fusions and splice variants across 517 cancer-associated genes, and calculates tumor mutation burden (TMB). The typical clinical workflow includes: specimen collection and accessioning at an outpatient clinic or hospital (ambulatory surgery center, hospital pathology lab, or reference lab), histologic confirmation of tumor content by a pathologist, extraction of nucleic acids, sequencing and bioinformatic analysis, and a finalized report returned to the ordering oncologist to guide systemic therapy selection or trial enrollment. Typical site of service: outpatient oncology clinic, hospital outpatient department, or reference molecular diagnostics laboratory. Service type: high-complexity molecular diagnostic laboratory testing (Proprietary Laboratory Analyses). Typical patient scenario: adult patients with advanced, recurrent, or metastatic solid tumors requiring broad genomic profiling for therapeutic and prognostic decision-making.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | No modifier required / billed as primary PLA code |