Summary & Overview
CPT 0329U: Oncomap ExTra NGS Tumor and Matched Normal Profiling
CPT code 0329U is a Proprietary Laboratory Analyses (PLA) CPT code for Oncomap™ ExTra, a comprehensive next‑generation sequencing (NGS) assay that performs whole exome DNA sequencing of solid tumor–associated genes and whole transcriptome RNA expression profiling, with matched normal DNA sequencing from blood or saliva. The code designates a single manufacturer‑specific test and matters nationally because it standardizes reporting for a high‑complexity molecular diagnostic that informs oncology care, clinical trial eligibility, and targeted therapy selection.
Key payers covered in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. The publication outlines payer coverage patterns, coding and billing considerations for PLA codes, and clinical context for use of comprehensive tumor profiling in solid tumors.
Readers will learn the clinical scope of the test, typical sites of service, and where to find information needed for claims submission. The report provides benchmark coverage summaries, policy highlights affecting PLA codes, and concise clinical context on how whole exome and whole transcriptome profiling with matched normal sequencing is used in oncology diagnostics. Data not available in the input is noted where applicable.
Billing Code Overview
CPT code 0329U is a Proprietary Laboratory Analyses (PLA) code specifically reported for Oncomap™ ExTra from Genomic Health Inc., a wholly owned subsidiary of Exact Sciences Inc. The test uses next‑generation sequencing (NGS) to perform whole exome DNA sequencing of genes associated with solid tumor mutations and whole transcriptome RNA expression profiling. The procedure also sequences DNA from blood or saliva to distinguish germline variants from tumor‑associated mutations.
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Service type: Comprehensive tumor profiling using NGS, including tumor DNA (whole exome), tumor RNA (whole transcriptome), and matched normal DNA from blood or saliva.
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Typical site of service: Clinical laboratories and specialized molecular diagnostics laboratories; testing is performed on tumor tissue with accompanying blood or saliva specimen collection.
Clinical & Coding Specifications
Clinical Context
A 62-year-old patient with a newly diagnosed metastatic adenocarcinoma of the lung undergoes a core needle tumor biopsy. The oncology team orders comprehensive tumor profiling to guide targeted therapy and immunotherapy decisions. Tissue is sent to the reference laboratory performing the proprietary Oncomap™ ExTra assay (0329U). The laboratory performs next-generation sequencing of tumor DNA (whole exome) and RNA (whole transcriptome) from the biopsy specimen and concurrently sequences germline DNA from a blood or saliva sample to exclude non-tumor (constitutional) variants. Results include somatic mutation profiling, transcriptomic signatures, and a report correlating actionable alterations to potential targeted agents or clinical trials. Typical workflow steps: preauthorization and order entry by the oncology clinic, specimen collection (tumor tissue and blood/saliva), courier to the specialty laboratory, laboratory processing and bioinformatics analysis, report generation, and results review by the treating oncologist to inform systemic therapy selection or genetic counseling referral.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
26 | Professional component | When billing only the professional (interpretive) component if the laboratory separates technical and professional charges and the payer requires it. |
TC | Technical component | When billing only the technical component for the laboratory processing and sequencing if payer requires separation. |
QK | Clinical laboratory improvement amendments (CLIA) waived test performed by lab personnel | Rarely used for high-complexity testing; generally not applicable but included for payer-specific reporting when required. |
QX | CLIA waived test performed by a non-waived laboratory personnel | See payer rules; include if a payer-specific modifier policy requires it for lab reporting distinctions. |
QY | Laboratory test order by a physician with an established relationship | Use per payer policy when ordering clinician relationship must be indicated. |
AS | Physician or other qualified health care professional services performed in active patient status | Use when service is provided as part of the treating clinician’s active management, per payer definitions. |
62 | Two surgeons or co-surgeons | Use if billing for surgical personnel services that contributed to obtaining the specimen and payer requires modifier for shared operative services. |
78 | Return to the operating room for a related procedure during the postoperative period | Use if a subsequent operative procedure to obtain additional tissue is required during the global period. |
80 | Assistant surgeon | Use when an assistant surgeon is billed for services related to obtaining the specimen, per payer policy. |
22 | Increased procedural services | Use when unusual effort is required to obtain sufficient tissue for the assay and the laboratory or operating clinician documents extraordinary work. |
52 | Reduced services | Use when the test cannot be completed as ordered or performed partially and the laboratory documents reduced service. |
53 | Discontinued procedure | Use when specimen collection was begun but discontinued for patient safety reasons. |
56 | Preoperative assessment only | Use when applicable to associated surgical services per payer rules. |
62 | Two surgeons or co-surgeons | See above; listed where co-surgical involvement in specimen procurement applies. |
23 | Unusual anesthesia | Use when significant anesthesia complications impacted specimen collection and modifier reporting is required. |
| Taxonomy Code | Specialty | Notes |
|---|---|---|
| 207RG0100X | Medical Oncology | Oncologists order tumor profiling for systemic therapy selection. |
| 2085P0207X | Molecular Genetic Pathology | Pathologists and molecular diagnosticians oversee test selection, specimen adequacy, and result interpretation. |
| 208D00000X | Anatomic Pathology | Surgical pathologists evaluate tissue, confirm diagnosis, and coordinate molecular testing. |
| 207L00000X | Hematology/Oncology | Hematologist-oncologists order comprehensive genomic profiling in advanced solid tumors. |
| 2084N0400X | Surgical Oncology | Surgical oncologists obtain tumor specimens and coordinate downstream testing. |
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
C34.90 | Malignant neoplasm of unspecified part of bronchus or lung, unspecified | Primary lung cancer is a common indication for comprehensive tumor genomic profiling to identify actionable mutations. |
C50.919 | Malignant neoplasm of unspecified site of unspecified female breast | Breast cancer specimens commonly undergo broad NGS and transcriptome analysis for treatment selection. |
C78.7 | Secondary malignant neoplasm of liver and intrahepatic bile duct | Metastatic lesions are often profiled when primary tumor genomics are not available or to detect resistance mechanisms. |
C18.9 | Malignant neoplasm of colon, unspecified | Colorectal cancers are frequently tested for DNA and RNA alterations to guide targeted therapy and trial eligibility. |
C71.9 | Malignant neoplasm of brain, unspecified | Some central nervous system tumors undergo comprehensive genomic and transcriptomic profiling for diagnostic and therapeutic guidance. |
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
88305 | Level IV surgical pathology, gross and microscopic examination | Performed prior to molecular testing to establish histologic diagnosis and determine specimen adequacy for 0329U. |
81210 | Oncology (e.g., EGFR) mutation analysis by sequencing, single gene (example code) | Single-gene tests may be ordered before or in addition to comprehensive NGS when specific mutations are suspected; may be redundant after 0329U but used in some workflows. |
81445 | Oncology (solid organ) assay, DNA-based molecular profiling, each additional gene (example panel) | Represents panel-based molecular profiling; 0329U is a proprietary whole-exome/transcriptome assay that provides broader data than many panel codes. |
87491 | Infectious organism DNA probe (example for germline validation) | Germline sequencing for comparison may use distinct molecular sequencing codes in some workflows; 0329U includes germline sequencing within the proprietary assay. |
99000 | Handling and processing of laboratory specimen (example ancillary) | Ancillary specimen handling and courier services are commonly billed around complex reference laboratory testing like 0329U. |