CPT 0485U: Caris Assure™ Plasma NGS for Solid Tumor Profiling
CPT code 0485U designates Caris Assure™, a proprietary plasma-based next-generation sequencing (NGS) assay that analyzes cell-free DNA and RNA to detect somatic alterations and biomarkers in solid tumors, including mutations, insertions/deletions, copy number changes, gene fusions, microsatellite instability, and tumor mutational burden. As a PLA code, 0485U is specific to a single manufacturer's test and is used for reporting that unique laboratory service nationally.
Key payers discussed include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise national overview of the code's clinical purpose and billing context, payer coverage considerations, and where the test fits within precision oncology workflows. The publication outlines benchmark and coverage topics relevant to PLA codes, summarizes typical sites of service and specimen handling, and highlights clinical implications for tumor profiling and biomarker-driven care.
This summary is written for a national audience and focuses on what CPT code 0485U represents, why it matters for molecular diagnostics and oncology care, and the practical billing and policy contexts stakeholders should consider. Data not available in the input are noted where applicable.
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Billing Code Overview
CPT code 0485U is a Proprietary Laboratory Analyses (PLA) code that applies exclusively to the Caris Assure™ test from Caris MPI Inc. (doing business as Caris Life Sciences®). The test uses next-generation sequencing of cell-free DNA and RNA from blood to identify genetic mutations, insertions/deletions, copy number alterations, gene fusions, microsatellite instability, and tumor mutational burden associated with solid tumors.
Service Type: Clinical laboratory molecular diagnostic (next-generation sequencing of circulating tumor-derived nucleic acids)
Typical Site of Service: Clinical laboratory testing performed on blood samples; specimen collection commonly occurs in outpatient clinics, physician offices, or phlebotomy centers, with analysis conducted in the performing laboratory.