Summary & Overview
CPT 0597U: AidaBreast™ Molecular Test for Breast Tumor Recurrence Risk
CPT code 0597U designates a proprietary molecular diagnostic test, AidaBreast™, developed by PreludeDx™ and Prelude Corporation. The assay analyzes preserved breast tumor tissue to measure RNA expression across 329 genes and protein levels for 20 analytes using next-generation sequencing and multiplex immunofluorescence; an algorithm integrates these data to estimate the tumor recurrence risk. As a PLA code, 0597U applies to a single manufacturer-specific test and is used when reporting this unique laboratory service.
Nationally, PLA codes like 0597U matter because they identify discrete, proprietary diagnostics that can influence treatment planning, coverage determinations, and utilization patterns for oncology care. Key payers discussed include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. The coverage landscape for proprietary genomic assays often varies by payer policy language, medical necessity criteria, and evidentiary standards.
Readers will find a concise overview of the clinical purpose and test methodology, the payers covered in this analysis, and what to expect in benchmarking and policy discussion sections. The publication summarizes payer coverage considerations, coding and billing implications for reporting a manufacturer-specific PLA code, and the clinical context in which the assay is applied. Data not available in the input are noted where applicable.
Billing Code Overview
CPT code 0597U is a Proprietary Laboratory Analyses (PLA) code for the AidaBreast™ test from PreludeDx™ and Prelude Corporation. The test evaluates a preserved sample of breast tumor tissue by measuring RNA expression from 329 genes and levels of 20 proteins. It uses next-generation sequencing and multiplex immunofluorescence to collect molecular data that are analyzed by an algorithm to estimate the risk of tumor recurrence.
Service Type: Clinical laboratory molecular diagnostic testing using next-generation sequencing and multiplex immunofluorescence.
Typical Site of Service: Independent clinical laboratory or specialty molecular diagnostics laboratory where preserved breast tumor tissue samples are processed and analyzed.
Clinical & Coding Specifications
Clinical Context
A typical patient is a woman recently diagnosed with early-stage invasive breast cancer following core needle biopsy or surgical resection. Tissue from a preserved formalin-fixed, paraffin-embedded (FFPE) tumor specimen is submitted to the laboratory performing AidaBreast™ (0597U) to measure RNA expression of 329 genes and levels of 20 proteins using next-generation sequencing and multiplex immunofluorescence. The test is ordered by the treating medical or surgical oncologist to estimate the probability of tumor recurrence and help inform decisions about adjuvant systemic therapy. Clinical workflow: the pathology team identifies adequate tumor tissue, confirms tumor content, prepares and ships the FFPE block or unstained slides with required documentation and diagnosis. The laboratory performs molecular and protein assays, runs the analytic algorithm, and returns a risk score and interpretive report to the ordering clinician. The oncologist integrates the result with clinical and pathologic features (tumor size, nodal status, grade, receptor status) to discuss prognosis and adjuvant treatment options with the patient.
Coding Specifications
-
Modifier | Description | When to Use
-
|---|---|
-
22| Increased procedural services | When documentation supports substantially greater complexity or work for the laboratory analysis or the reporting process beyond typical test performance and this is allowable by payer policy. -
52| Reduced services | When the laboratory provided a partially reduced test or partial analytic process such that full test components were not completed but billing needs to reflect reduced service.