Summary & Overview
CPT 0262U: OncoSignal 7 Pathway Signal RT-PCR Assay for FFPE Tumor Tissue
CPT code 0262U designates the OncoSignal 7 Pathway Signal proprietary laboratory test from Protean BioDiagnostics and Philips Electronics, Nederland. The RT–PCR–based assay analyzes FFPE cancer tissue to measure activity across seven gene pathways and reports pathway activity scores via a diagnostic algorithm. As a PLA code, 0262U is specific to a single test and manufacturer, which has implications for coding, billing, and payer policy nationwide.
Key payers in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise overview of the code's clinical purpose, the service setting, and the typical use case for oncology therapeutic selection. The publication summarizes payer coverage patterns, billing considerations for a PLA code, and operational implications for laboratory and clinical workflows. It also outlines where stakeholders can expect policy scrutiny or prior authorization requirements given the proprietary nature of the assay.
This report is intended to inform billing professionals, laboratory directors, and oncology clinicians about the role of 0262U in molecular diagnostics, common reimbursement touchpoints, and the clinical context in which pathway activity scoring is reported.
Billing Code Overview
CPT code 0262U is a Proprietary Laboratory Analyses (PLA) code that applies only to the OncoSignal 7 Pathway Signal test produced by Protean BioDiagnostics and Philips Electronics, Nederland. The assay uses real-time reverse-transcription polymerase chain reaction (RT–PCR) on formalin–fixed paraffin–embedded (FFPE) cancer tissue specimens to evaluate gene pathway activity for seven biological pathways associated with tumor growth. Results are processed by an algorithm to generate pathway activity scores that may aid in selection of appropriate therapy.
Service Type: Proprietary molecular diagnostic test (laboratory-based genomic assay)
Typical Site of Service: Clinical diagnostic laboratory using FFPE cancer tissue specimens
Data not available in the input.
Clinical & Coding Specifications
Clinical Context
A 62‑year‑old patient with a newly diagnosed invasive epithelial carcinoma provides a formalin‑fixed paraffin‑embedded (FFPE) tumor tissue block after surgical resection. The treating oncologist orders a tumor biology assay, the OncoSignal 7 Pathway Signal test (0262U), to quantify activity of seven signaling pathways via real‑time reverse‑transcription PCR (RT‑PCR) and an algorithmic pathway activity score. The clinical workflow: the pathology team confirms tumor content and prepares an FFPE specimen or unstained slides; the specimen is sent to the performing laboratory (Protean BioDiagnostics / Philips) with appropriate test requisition and patient identifiers; laboratory performs RNA extraction, RT‑PCR, and proprietary algorithmic analysis; results are reported to the ordering medical oncologist and pathology service to inform discussion of biologic drivers and potential therapy selection. Typical site of service is a commercial clinical reference laboratory or hospital outpatient pathology/lab facility. Service type: Proprietary Laboratory Analysis (PLA) molecular diagnostic test performed on tumor FFPE tissue.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | No modifier | Used when no special reporting modifier applies; standard billing for the PLA test |
26 | Professional component | Use when billing only the professional component (interpretation/analysis) separate from technical laboratory processing |
TC | Technical component | Use when billing only the technical component (performing assay, processing specimen) |
52 | Reduced services | Use if the test was partially performed or limited compared with the full assay scope |
53 | Discontinued procedure | Use if testing was started but discontinued for documented medical reasons prior to completion |
59 | Data not available in the input. | Data not available in the input. |
62 | Two surgeons | Rarely applicable; retained if a second qualified provider is involved in a related service requiring this modifier |
78 | Unplanned return to the operating/procedure room | Use only when a surgical/procedural complication requires repeat operative management associated with specimen procurement |
80 | Assistant at surgery | Use when an assistant surgeon is billed for a related surgical specimen collection procedure |
| Taxonomy Code | Specialty | Notes |
|---|---|---|
| 208000000X | Anatomic/Clinical Pathology | Pathologists who confirm specimen adequacy and direct testing |
| 207P00000X | Medical Oncology | Ordering clinicians who use assay results to guide systemic therapy |
| 207L00000X | Hematology/Oncology | Specialists involved in cancer diagnosis and treatment planning |
| 183500000X | Clinical Laboratory | Laboratory directors and technical staff performing molecular diagnostics |
| 2086S0102X | Molecular Genetic Pathology | Specialists overseeing molecular assay validation and interpretation |
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
C50.919 | Malignant neoplasm of unspecified site of right female breast | Breast cancers frequently undergo molecular pathway profiling to guide targeted or systemic therapy decisions |
C34.90 | Malignant neoplasm of unspecified part of unspecified bronchus or lung | Lung carcinomas are commonly profiled with pathway and molecular assays to inform therapy selection |
C18.9 | Malignant neoplasm of colon, unspecified | Colorectal tumors may be tested for pathway activity to support therapeutic decision making |
C71.9 | Malignant neoplasm of brain, unspecified | Primary brain tumors can undergo molecular pathway testing when tissue availability permits |
C80.1 | Malignant (primary) neoplasm, unspecified | Advanced or metastatic cancers where pathway profiling may assist in therapy selection |
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
88305 | Level IV surgical pathology, gross and microscopic examination | Pathology evaluation of tumor tissue before selection and forwarding of FFPE blocks for molecular testing |
88342 | Immunohistochemistry, per single antigen; initial label/antibody | Common ancillary test performed on FFPE tissue to characterize tumor markers alongside pathway assays |
88360 | Morphometric analysis; tumor immunohistochemistry quantification | Quantitative assessment sometimes paired with molecular pathway reporting |
81162 | BRCA1 and BRCA2 analysis, full sequence analysis (example hereditary testing) | Example of other molecular oncology tests that may be ordered in parallel for comprehensive tumor profiling |
0002U | Data not available in the input. | Data not available in the input. |