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 | Technical component | Use when reporting only the technical processing component (laboratory processing) if payer requires split billing. |
59 | Data not available in the input. | Data not available in the input. |
QK | Advanced Diagnostic Laboratory Test (ADLT) modifier for entities performing test | Use when the lab meets ADLT status requirements and payer policy requests ADLT designation. |
QX | CLIA Waiver/Complexity modifier pair (personalized) | Use in conjunction with QK when the test is performed under specific laboratory certification conditions per payer guidelines. |
QY | Data not available in the input. | Data not available in the input. |
AS | Physician assistant, nurse practitioner, or clinical nurse specialist services | Use when a mid-level provider performs an associated clinic visit or orders the test where payer requires modifier reporting. |
82 | Assistant surgeon (when qualified resident not available) | Generally not applicable to this laboratory test but included among relevant clinical modifiers for associated procedures. |
22 | Increased procedural services | Use if additional work beyond the typical service is required for specimen handling or sequencing when payer allows modifier for unusual effort. |
52 | Reduced services | Use when the test performed is substantially reduced from the full panel per clinical order. |
53 | Discontinued procedure | Use if specimen collection or processing is aborted and payer requires reporting of discontinued service. |
78 | Unplanned return to the operating/procedure room by the same physician following initial procedure for a related procedure during the postoperative period | Usually not applicable to this lab test; included for completeness when surgical procedures are part of the patient workflow. |
80 | Assistant surgeon | Not typically applicable to this lab test; included for completeness. |
11 | Data not available in the input. | Data not available in the input. |
| Taxonomy Code | Specialty | Notes |
|---|---|---|
207RC0000X | Hematology & Oncology | Medical oncologists commonly order comprehensive genomic profiling for treatment selection. |
207RH0000X | Medical Oncology | Oncology subspecialists managing systemic therapy decisions use cfDNA results for targeted therapy matching. |
208D00000X | Pathology | Molecular pathologists and laboratory directors oversee test validation and reporting. |
363L00000X | Clinical Laboratory | Clinical laboratory geneticists and molecular diagnostics specialists perform and interpret NGS assays. |
207LP2900X | Pulmonology | Pulmonologists may order testing for lung cancer patients when coordinating diagnosis and management. |
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
C34.90 | Malignant neoplasm of unspecified part of unspecified bronchus or lung | Common primary diagnosis for which plasma cfDNA NGS is ordered to identify actionable mutations in lung cancer. |
C50.912 | Malignant neoplasm of unspecified site of left female breast | Breast cancer patients with metastatic disease may have cfDNA testing to detect targetable alterations or resistance mutations. |
C18.9 | Malignant neoplasm of colon, unspecified | Metastatic colorectal cancer may be evaluated with plasma NGS for RAS, BRAF and other actionable alterations. |
C61 | Malignant neoplasm of prostate | Advanced prostate cancer patients may undergo cfDNA testing to identify genomic drivers and treatment options. |
C80.1 | Malignant (primary) neoplasm, unspecified | Used when primary tumor site is unknown and comprehensive genomic profiling is needed to guide therapy. |
C78.7 | Secondary malignant neoplasm of liver and intrahepatic bile duct | Metastatic disease to liver often triggers genomic profiling to guide systemic therapy selection. |
Z85.118 | Personal history of other malignant neoplasm of bronchus and lung | Used in surveillance contexts where recurrence or new actionable alterations are suspected. |
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
36415 | Collection of venous blood by venipuncture | Specimen collection for the cfDNA assay; performed at the clinic or phlebotomy site prior to sending sample to the laboratory. |
88360 | Morphometric or special staining procedures, interpretation and report (molecular pathology procedures often billed separately) | May be used for accompanying tissue-based molecular tests or ancillary pathology work when tumor biopsy tissue is also processed. |
81445 | Oncology (solid organ) targeted genomic sequence analysis panel, single gene or small panel (example; see payer-specific guidance) | Represents alternative or complementary targeted sequencing tests performed on tissue specimens alongside the plasma NGS assay. |
81479 | Unlisted molecular pathology procedure | Used when a specific molecular test lacks a precise CPT analogue for reporting additional or unique laboratory analyses related to genomic profiling. |
0034U | Proprietary Laboratory Analyses (example PLA) | Represents other PLA codes that may be reported for distinct proprietary genomic tests; listed as related in workflows where multiple FDA-cleared/PLA assays are considered. |