# BluePrint

Source: https://onco.cc/drugs/blueprint/  
OnCo record `blueprint` (Test). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

An 80-gene tissue test that sorts an early breast cancer into one of three biological types, used alongside MammaPrint.

## Summary

Agendia describes BluePrint as "an 80-gene molecular subtyping test" that classifies tumours as luminal, HER2-type or basal-type, and states that it "is a laboratory-developed test" which "has not been cleared by the U.S. Food and Drug Administration (FDA) but has been CE-marked for use in Europe". In the development study 56 per cent of patients in the basal-type group and 50 per cent in the HER2-type group had a pathological complete response to neoadjuvant chemotherapy (Krijgsman 2012). Medicare's Palmetto MolDX article A53484 (effective 1 April 2026) states that there is insufficient evidence of clinical utility and that "the BluePrint test is a statutorily excluded test".

## Fields

- Kind: Test
- Status: established
- Last checked: 2026-11-04
- Also known as: Agendia BluePrint; BluePrint 80-gene
- Tags: test; rna
- Brand: BluePrint
- Modality: Gene-expression molecular subtyping assay (80 genes, breast cancer)
- Mechanism: Expression of 80 genes in breast tumour tissue classifies the tumour as luminal-type, HER2-type or basal-type, usually reported alongside MammaPrint.

## Sources

- Agendia: BluePrint: https://agendia.com/blueprint/
- CMS article A53484: Billing and Coding: MolDX: BluePrint Test: https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=53484

## Connected records

- drugs: [MammaPrint (70-gene signature)](https://onco.cc/drugs/mammaprint/)
- cancers: [Breast cancer (all types)](https://onco.cc/cancers/breast-cancer/)
- technologies: [Gene-expression prognostic assays](https://onco.cc/technologies/gene-expression-prognostic-assays/), [RNA sequencing & expression profiling](https://onco.cc/technologies/rna-seq/)
- companies: [Agendia](https://onco.cc/companies/agendia/)
- key papers: [A diagnostic gene profile for molecular subtyping of breast cancer associated with treatment response](https://onco.cc/key-papers/paper-krijgsman-blueprint-subtyping-breast-cancer-res-treat-2012/)

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