Summary & Overview
CPT 0326U: Guardant360® NGS Cell-Free DNA Solid Tumor Panel
CPT code 0326U designates the Guardant360® Proprietary Laboratory Analyses (PLA) test, a next-generation sequencing (NGS) targeted panel that analyzes cell-free circulating DNA from blood to assess 83+ genes associated with solid-organ neoplasms. As a PLA code, 0326U is specific to one manufacturer and test and is used when reporting Guardant360® results. Nationally, this code matters because it standardizes billing for a widely used liquid biopsy that influences diagnostic evaluation, therapeutic selection, and longitudinal monitoring in oncology.
Key payers examined include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. The analysis covers payer coverage patterns, reimbursement benchmarks, and clinical context for use of a multi-gene cfDNA NGS panel in solid tumors.
Readers will learn the clinical scope of the test, typical sites of service, common billing modifiers associated with lab services, and where to find related coding and policy considerations. The publication provides benchmarks for payer coverage and coding practices, notes policy updates affecting proprietary NGS assays, and summarizes clinical scenarios where a broad cfDNA panel is used. Data not available in the input is identified where applicable.
Billing Code Overview
CPT code 0326U is a Proprietary Laboratory Analyses (PLA) code that applies exclusively to the Guardant360® test from Guardant Health Inc. The test uses next-generation sequencing (NGS) targeted sequence analysis of cell-free circulating DNA from a blood specimen to evaluate 83 or more genes associated with solid-organ neoplasms.
Service Type: Laboratory — Proprietary NGS tumor profiling on circulating cell-free DNA
Typical Site of Service: Clinical laboratory or outpatient phlebotomy setting for blood collection; testing performed in a reference laboratory
Clinical & Coding Specifications
Clinical Context
A 62-year-old patient with a history of metastatic non-small cell lung cancer (NSCLC) presents for evaluation of targeted therapy options after progression on first-line chemotherapy. The oncologist orders a blood-based comprehensive genomic profiling test to identify actionable somatic alterations when tissue biopsy is infeasible or insufficient. A peripheral blood draw is performed in the outpatient oncology clinic or an ambulatory phlebotomy lab. The specimen is shipped to the performing laboratory (Guardant Health) for next-generation sequencing (NGS) of cell-free circulating tumor DNA (cfDNA) using the Guardant360® assay, which evaluates 83 or more genes associated with solid-organ neoplasms. Results are returned to the ordering provider and integrated into the patient’s oncology treatment plan to guide systemic therapy selection, enrollment in clinical trials, or further tissue testing if needed.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | No modifier — default | Use when no specific modifier applies to the service. |
22 | Increased procedural services | Use when documentation supports substantially greater work, complexity, or time for test-related activities beyond typical processing or interpretation. |