{"entity":{"id":"blueprint","kind":"drug","name":"BluePrint","aka":["Agendia BluePrint","BluePrint 80-gene"],"tldr":"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\".","status":"established","asOf":"2026-11-04","links":[{"label":"Agendia: BluePrint","url":"https://agendia.com/blueprint/"},{"label":"CMS article A53484: Billing and Coding: MolDX: BluePrint Test","url":"https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=53484"}],"tags":["test","rna"],"related":["mammaprint"],"cancers":["breast-cancer"],"sections":[],"technologies":["gene-expression-prognostic-assays","rna-seq"],"targets":[],"drugs":[],"companies":["agendia"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-krijgsman-blueprint-subtyping-breast-cancer-res-treat-2012"],"journals":[],"dependsOn":[],"notes":[],"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.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[{"country":"US","reimbursement":"Not covered by Medicare: Palmetto MolDX article A53484 calls BluePrint a statutorily excluded test for breast cancer subtyping (effective 1 April 2026)","source":"https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=53484","asOf":"2026-11-04"}],"regulatoryEvents":[]},"route":"/drugs/blueprint/","neighbours":{"drug":[{"id":"mammaprint","kind":"drug","name":"MammaPrint (70-gene signature)","route":"/drugs/mammaprint/"}],"cancer":[{"id":"breast-cancer","kind":"cancer","name":"Breast cancer (all types)","route":"/cancers/breast-cancer/"}],"technology":[{"id":"gene-expression-prognostic-assays","kind":"technology","name":"Gene-expression prognostic assays","route":"/technologies/gene-expression-prognostic-assays/"},{"id":"rna-seq","kind":"technology","name":"RNA sequencing & expression profiling","route":"/technologies/rna-seq/"}],"company":[{"id":"agendia","kind":"company","name":"Agendia","route":"/companies/agendia/"}],"paper":[{"id":"paper-krijgsman-blueprint-subtyping-breast-cancer-res-treat-2012","kind":"paper","name":"A diagnostic gene profile for molecular subtyping of breast cancer associated with treatment response","route":"/key-papers/paper-krijgsman-blueprint-subtyping-breast-cancer-res-treat-2012/"}]}}