MolDX: Prometheus IBD sgi Diagnostic Policy

Summary of Evidence Analysis of Evidence General Information Associated Information Sources of Information Bibliography Revision History Information Associated Documents Attachments Related Local Coverage Documents Related National Coverage Documents Public Versions Keywords Local Coverage Determination (LCD) MolDX: Prometheus® IBD sgi Diagnostic® Policy L37260 Expand All | Collapse All  Email Document  Download  Add to basket Contractor Information Contractor Name Contract Type Contract Number Jurisdiction States LCD Information Document Information LCD ID L37260 LCD Title MolDX: Prometheus® IBD sgi Diagnostic® Policy Proposed LCD in Comment Period N/A Source Proposed LCD DL37260 Original Effective Date For services performed on or after 09/26/2017 Revision Effective Date For services performed on or after 03/13/2025 Revision Ending Date N/A Retirement Date N/A Notice Period Start Date 08/10/2017 Notice Period End Date 09/25/2017 CPT codes, descriptions, and other data only are copyright 2025 American Medical Association. All Rights Reserved. Fee schedules, relative value units, conversion factors and/or re

This is a non-coverage policy for the Prometheus ® IBD sgi Diagnostic ® test. The intended use of this test is to aid healthcare providers in differentiating inflammatory bowel disease (IBD) vs non-IBD, and Crohn’s disease (CD) vs Ulcerative Colitis (UC) in a comprehensive blood test. The test includes 9 serological markers: ASCA IgA, ASCA IgG, anti-OmpC IgA, anti-CBir1 IgG, anti-A4 Fla2 IgG, anti-FlaX IgG, IBD-specific pANCA auto-antibody, IBD-specific pANCA IFA (perinuclear pattern), IBD-specific pANCA IFA DNAse Sensitivity; 4 genetic immune response markers (SNPs): ATG16L1, STAT3, NKX2-3, and ECM1; and 5 inflammatory biomarkers: ICAM-1, VCAM-1, VEGF, CRP and SSA. A proprietary Smart Diagnostic Algorithm interprets patterns among the multiple assay values to produce an IBD score. The test results are reported as “consistent with IBD” (consistent with UC; consistent with CD, or inconclusive for UC vs CD) or “not consistent with IBD”. In addition to the algorithmic test interpretation, the results of the 17 biomarkers are also individually reported.