Anthem Blue Cross Connecticut LAB.00033 Protein Biomarkers for the Screening, Detection and Management of Prostate Cancer Form

This document addresses the use of protein biomarkers for the screening, detection and management of prostate cancer, for example: IsoPSA™ (Cleveland Diagnostics, Inc.; Cleveland, OH), 4Kscore test (OPKO Diagnostics, LLC; Woburn, MA), Androgen Receptor Splice Variant-7 (AR-V7), and PanGIA Prostate (Genetics Institute of America; DelRay, FL). This document does not address prostate-specific antigen (PSA) testing.

Note: Please see the following related document(s) for additional information:

• GENE.00009 Gene Expression Profiling and Genomic Biomarker Tests for Prostate Cancer
• LAB.00015 Detection of Circulating Tumor Cells

Position Statement

Investigational and Not Medically Necessary:

The use of protein biomarker tests for the screening, detection, and management of prostate cancer is considered investigational and not medically necessary.