Summary & Overview
CPT 0458U: Auria® Tear‑Fluid ELISA for S100A8/S100A9 Risk Score
CPT code 0458U is a Proprietary Laboratory Analyses (PLA) code that identifies Auria®, a tear‑fluid ELISA from Namida Lab Inc. measuring proteins S100A8 and S100A9 and producing an algorithmic risk score for potential breast cancer. As a PLA code, 0458U is specific to a single manufacturer's test and signals the use of a proprietary biomarker plus computational analysis in clinical decision support. Nationally, such PLA codes matter because they represent precision diagnostics that can influence screening and diagnostic pathways and raise questions about coverage policies, clinical utility evidence, and laboratory billing practices.
Key payers discussed include Aetna, Blue Cross Blue Shield plans, Cigna, UnitedHealthcare, and Medicare. Readers will find a concise overview of the code's clinical context, typical service setting, and payer landscape. The publication outlines benchmarks and coverage considerations relevant to proprietary biomarker tests, summarizes policy and reimbursement themes commonly applied by major payers, and situates the test within current diagnostic workflows for breast cancer risk evaluation. Data not available in the input will be noted where specific coverage or utilization figures would normally appear.
Billing Code Overview
CPT code 0458U is a Proprietary Laboratory Analyses (PLA) code that applies to a single, specific laboratory test: Auria® from Namida Lab Inc. The test is an enzyme–linked immunosorbent assay (ELISA) performed on a tear‑fluid specimen to evaluate the proteins S100A8 and S100A9. An algorithmic analysis of those protein measurements produces a risk score intended to inform decisions about whether to pursue further diagnostic evaluation for breast cancer.
Service type: Proprietary laboratory diagnostic test (PLA), biomarker assay with algorithmic risk scoring.
Typical site of service: Clinical laboratory or reference laboratory setting; specimen collection can occur in outpatient clinics or specialty offices capable of tear‑fluid sampling.
Clinical & Coding Specifications
Clinical Context
A 52-year-old woman presents to a specialty breast clinic for risk stratification after an equivocal screening mammogram and a family history of breast cancer. She is asymptomatic but requests additional, noninvasive testing to help guide shared decision-making about whether to proceed with diagnostic imaging (diagnostic mammography, ultrasound) or short-interval follow-up. The clinic collects a tear-fluid specimen in the outpatient clinic during the visit. The specimen is sent to Namida Lab Inc. for analysis by the proprietary Auria® assay, which uses an ELISA to measure S100A8 and S100A9 levels and an algorithm to generate a risk score indicating likelihood of underlying breast malignancy. The test report is returned to the ordering clinician who incorporates the risk score into the diagnostic plan; additional procedures (imaging, biopsy) are ordered as indicated by the score and clinical judgment.
Typical service type: Proprietary Laboratory Analysis (PLA) of a biologic specimen using an immunoassay with algorithmic risk scoring.
Typical site of service: Outpatient clinic or ambulatory specialty clinic (specimen collection) with testing performed at the manufacturer’s or reference laboratory.
Typical patient workflow: patient encounter and consent → tear-fluid collection by clinic staff → specimen shipping → laboratory ELISA and algorithmic analysis → result transmitted to ordering clinician → care plan adjusted (imaging, biopsy, surveillance) based on risk score.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 |