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 |