Summary & Overview
CPT 0242U: Guardant360 CDx NGS ctDNA Tumor Profiling
CPT code 0242U designates Guardant360® CDx, a Proprietary Laboratory Analyses (PLA) next‑generation sequencing (NGS) assay that evaluates cell‑free DNA from a blood specimen for 55–74 genes implicated in solid‑organ tumors. As a PLA code, 0242U applies to a single manufacturer‑specific test and is used for reporting comprehensive circulating tumor DNA (ctDNA) genomic profiling. Its national relevance stems from growing use of liquid biopsy for targeted oncology care, treatment selection, and clinical trial eligibility.
Key payers covered in this analysis include Aetna, Blue Cross Blue Shield, Cigna, UnitedHealthcare, and Medicare. Readers will find benchmarks and coverage landscape context for payer handling of PLA NGS testing, an overview of clinical utility considerations for ctDNA tumor profiling, and descriptions of typical billing and service settings. The publication outlines common modifier usage and the test’s positioning within laboratory and oncology service lines. Where payer‑specific coverage details are unavailable, the report notes that data is not provided in the input.
This summary serves clinicians, laboratory billing staff, and policy analysts seeking concise information on coding, clinical application, and the payer environment for CPT code 0242U without making clinical recommendations.
Billing Code Overview
CPT code 0242U is a Proprietary Laboratory Analyses (PLA) code assigned to Guardant360® CDx from Guardant Health, Inc. The test uses next generation sequencing (NGS) to evaluate cell–free DNA from a blood specimen for 55–74 genes associated with solid‑organ tumors. This assay is a tumor profiling, genomic sequencing service performed on a patient blood sample.
Service type: Laboratory — next generation sequencing (NGS) for circulating tumor DNA (ctDNA) tumor profiling
Typical site of service: Clinical laboratory or hospital outpatient laboratory; specimen collection commonly occurs in an outpatient clinic or phlebotomy setting.
Clinical & Coding Specifications
Clinical Context
A 62-year-old patient with a history of metastatic non-small cell lung carcinoma (NSCLC) presents with progressive disease despite first-line therapy. The oncologist orders a blood-based comprehensive tumor genomic profiling test to identify actionable somatic alterations to guide targeted therapy selection and determine eligibility for clinical trials. A venous blood specimen is collected in an outpatient oncology clinic or phlebotomy lab. The sample is sent to the manufacturer-associated laboratory for processing. The test, reported using 0242U for Guardant360® CDx, uses next-generation sequencing of cell‑free DNA (cfDNA) to evaluate a panel of 55–74 genes associated with solid-organ tumors. Results are returned to the ordering provider and incorporated into the treatment planning visit; additional sequencing, tumor biopsy, or targeted therapy administration occur in subsequent encounters as indicated.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
26 | Professional component | Use when reporting only the professional component interpretation of the test if separated by payer policy. |
TC |