Summary & Overview
CPT 0471U: RAS Mutation Detection for Colorectal Cancer (PCR, FFPE)
CPT code 0471U designates a Proprietary Laboratory Analyses (PLA) test — the CRCdx® RAS Mutation Detection Kit from EntroGen Inc. — used to identify 35 specific KRAS and NRAS variants in colorectal cancer tissue. The code matters nationally because it captures a manufacturer-specific molecular diagnostic that informs targeted oncology care and payer coverage decisions. Its PLA status signals single-source ownership, which affects coding, reporting, and pricing transparency.
Key payers in the analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise clinical context for the test, a summary of typical sites of service, and an outline of common modifier usage relevant to laboratory services. The publication highlights what to expect in terms of coding classification, the clinical role of RAS mutation testing in colorectal cancer, and operational considerations for submitting claims using a PLA CPT code.
This overview is intended for national audiences including laboratory billing staff, oncology program administrators, and payer policy analysts seeking clear information on the coding and clinical context of a manufacturer-specific RAS mutation assay.
Billing Code Overview
CPT code 0471U is a Proprietary Laboratory Analyses (PLA) code assigned exclusively to the CRCdx® RAS Mutation Detection Kit from EntroGen Inc. The test uses qualitative real–time polymerase chain reaction (PCR) to detect 35 specific variants in the KRAS and NRAS genes across exons 2, 3, and 4. The assay is performed on formalin–fixed paraffin–embedded (FFPE) tissue samples, which preserve tumor tissue for molecular analysis.
Service Type: Molecular pathology / companion diagnostic testing
Typical Site of Service: Clinical laboratory or reference molecular diagnostics laboratory
Clinical & Coding Specifications
Clinical Context
A 62-year-old patient with newly diagnosed metastatic colorectal adenocarcinoma undergoes surgical resection of the primary tumor. Formalin–fixed paraffin–embedded (FFPE) tumor tissue from the resection or diagnostic biopsy is sent to a reference molecular laboratory. The lab performs the CRCdx® RAS Mutation Detection Kit (EntroGen Inc.) using qualitative real‑time PCR to detect 35 KRAS and NRAS variants in exons 2, 3, and 4. The resulting RAS mutation status informs systemic therapy selection (for example, eligibility for anti‑EGFR monoclonal antibody therapy) and may be requested as part of a comprehensive molecular profile. Typical workflow steps: tissue accessioning and grossing at the surgical pathology or histology lab; FFPE sectioning and tumor enrichment if indicated; nucleic acid extraction and quality assessment; PCR assay using the proprietary CRCdx® kit; result interpretation by molecular pathology personnel; and report issuance to the treating oncologist. Typical site of service: outpatient hospital laboratory or independent reference molecular pathology laboratory. Service type: molecular oncology diagnostic test performed on FFPE tumor tissue.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | Default or not specified | Rarely used; indicates standard service when no other modifier applies. |