Anthem Blue Cross Connecticut Commercial Clinical Policy

Anthem Blue Cross Connecticut LAB.00011 Selected Protein Biomarker Algorithmic Assays Form

Effective Date

09/27/2023

Last Reviewed

08/10/2023

Original Document

  Reference



This document addresses the use of selected protein biomarker algorithmic assays, which involve the qualitative and/or quantitative analysis of protein constituents in a biological sample that are reported as a predictive, diagnostic or prognostic algorithmic result. Protein biomarker algorithmic assays are under investigation in certain tumors and for other applications such as predicting the likelihood of preterm delivery in pregnancy.

Please see the following related documents for additional information on protein biomarker tests for specific indications:

  • LAB.00033 Protein Biomarkers for the Screening, Detection and Management of Prostate Cancer
  • LAB.00035 Multi-biomarker Disease Activity Blood Tests for Rheumatoid Arthritis
  • LAB.00037 Serologic Testing for Biomarkers of Irritable Bowel Syndrome (IBS)
  • LAB.00040 Serum Biomarker Tests for Risk of Preeclampsia
  • LAB.00048 Pain Management Biomarker Analysis

Position Statement

Investigational and Not Medically Necessary:

The following protein biomarker algorithmic assays are considered investigational and not medically necessary for all indications:

  1. BDX-XL2 (Nodify XL2®)
  2. EarlyCDT®-Lung test (Nodify CDT®)
  3. IMMray® PanCan-d
  4. LC-MS/MS Targeted Proteomic Assay
  5. PreTRM
  6. REVEAL Lung Nodule Characterization
  7. Theralink® Reverse Phase Protein Array
  8. VeriStrat®.

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