{"entity":{"id":"prosigna","kind":"drug","name":"Prosigna (PAM50)","aka":[],"tldr":"A 50-gene test run in local hospital laboratories that estimates the ten-year risk of a hormone-positive breast cancer coming back.","summary":"Prosigna was cleared by the FDA on 6 September 2013 (510(k) K130010, NanoString; now marketed by Veracyte) for postmenopausal women with hormone-receptor-positive, node-negative or one-to-three-node-positive early breast cancer treated with endocrine therapy. Validation came from the ABCSG-8 and TransATAC cohorts, where the ROR score predicted distant recurrence at 10 years, including late recurrence after five years. NICE diagnostics guidance DG34 (2018) recommends Prosigna, Oncotype DX and EndoPredict for guiding adjuvant chemotherapy decisions in the NHS. Because it runs on a decentralised instrument, it is common in Europe where send-out testing is less used.","status":"approved","asOf":"2026-09-10","links":[{"label":"FDA 510(k) K130010","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K130010"},{"label":"NICE DG34: tumour profiling tests for breast cancer","url":"https://www.nice.org.uk/guidance/dg34"}],"tags":["test"],"related":["oncotype-dx","mammaprint","endopredict"],"cancers":["breast-hr-positive"],"sections":[],"technologies":["rna-seq"],"targets":[],"drugs":[],"companies":["veracyte"],"institutions":[],"pathways":[],"terms":["biomarker"],"trials":["nct02653755"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["What a result means: a low ROR score means chemotherapy is unlikely to help on top of hormone therapy; a high score means it is likely to be recommended."],"brand":"Prosigna","modality":"Gene-expression prognostic assay (50-gene PAM50 risk of recurrence)","mechanism":"nCounter digital expression of 50 classifier genes assigns an intrinsic subtype (luminal A, luminal B, HER2-enriched, basal-like) and a risk-of-recurrence (ROR) score combined with tumour size and nodal status.","approvals":[{"region":"US","year":2013,"indication":"Prognosis of distant recurrence in postmenopausal HR+ early breast cancer (510(k))"},{"region":"EU","year":2012,"indication":"CE-IVD"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/prosigna/","neighbours":{"drug":[{"id":"endopredict","kind":"drug","name":"EndoPredict","route":"/drugs/endopredict/"},{"id":"mammaprint","kind":"drug","name":"MammaPrint (70-gene signature)","route":"/drugs/mammaprint/"},{"id":"oncotype-dx","kind":"drug","name":"Oncotype DX","route":"/drugs/oncotype-dx/"}],"cancer":[{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"}],"technology":[{"id":"rna-seq","kind":"technology","name":"RNA sequencing & expression profiling","route":"/technologies/rna-seq/"}],"company":[{"id":"veracyte","kind":"company","name":"Veracyte (Decipher)","route":"/companies/veracyte/"}],"term":[{"id":"biomarker","kind":"term","name":"Biomarker","route":"/terms/biomarker/"}],"trial":[{"id":"nct02653755","kind":"trial","name":"The PRECISION Trial (Profiling Early Breast Cancer for Radiotherapy Omission): A Phase II Study of Breast-Conserving Surgery Without Adjuvant Radiotherapy for Favorable-Risk Breast Cancer","route":"/trials/nct02653755/"}],"roadmap":[{"id":"diagnostics-roadmap","kind":"roadmap","name":"Diagnostics roadmap: stains → gene panels → blood tests that decide treatment","route":"/roadmaps/diagnostics-roadmap/"}]}}