{"entity":{"id":"oncotype-dx","kind":"drug","name":"Oncotype DX","aka":[],"tldr":"A 21-gene test that tells most women with early hormone-positive breast cancer whether they can safely skip chemotherapy.","summary":"Oncotype DX is a gene-expression assay that measures 16 cancer-related and 5 reference genes by RT-PCR in tumour tissue to give a recurrence score estimating both the risk of distant recurrence and the likely benefit from chemotherapy in early hormone-positive, HER2-negative breast cancer. TAILORx (2018) showed that women with a score of 25 or below, if over 50, derive no benefit from adding chemotherapy to endocrine therapy, and RxPONDER extended that finding to postmenopausal women with 1 to 3 positive nodes. Younger women with mid-range scores did show some chemotherapy benefit in TAILORx, which may reflect ovarian suppression rather than cytotoxic effect, and this remains debated. Exact Sciences markets it; MammaPrint (Agendia) and Prosigna/PAM50 are alternatives. For a newcomer: a tumour test that lets most women with early hormone-positive breast cancer safely skip chemotherapy.","status":"established","asOf":"2026-09-04","links":[{"label":"TAILORx (NEJM 2018)","url":"https://doi.org/10.1056/NEJMoa1804710"},{"label":"NICE DG34: tumour profiling tests for breast cancer","url":"https://www.nice.org.uk/guidance/dg34"}],"tags":[],"related":["mammaprint","prosigna","endopredict","genomic-assay-to-chemo-omission"],"cancers":["breast-hr-positive","hr-positive-early-high-risk"],"sections":[],"technologies":["rna-seq","companion-diagnostic","gene-expression-prognostic-assays"],"targets":[],"drugs":[],"companies":["exact-sciences"],"institutions":[],"pathways":[],"terms":[],"trials":["tailorx","rxponder"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"modality":"Gene-expression prognostic/predictive assay","mechanism":"RT-PCR of 16 cancer and 5 reference genes into a recurrence score.","approvals":[],"mechanismSteps":["RNA is extracted from the tumour block","Expression of 16 cancer genes and 5 reference genes is measured by RT-PCR","A recurrence score from 0 to 100 is computed","Score and menopausal status predict chemotherapy benefit"],"toxicity":[],"access":[{"country":"US","listPrice":"~$4,500 list price","reimbursement":"Medicare and most commercial plans for node-negative and node-positive (1-3) HR+/HER2- early breast cancer","source":"https://www.oncotypeiq.com","asOf":"2026-09-06"},{"country":"UK","reimbursement":"NICE: recommended for ER+/HER2- node-negative and some node-positive early breast cancer (DG58)","source":"https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance","asOf":"2026-09-06"}],"regulatoryEvents":[{"date":"2004-01","type":"filing","region":"US","note":"Launched as a laboratory-developed test","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2018-06-03","type":"label-change","region":"US","note":"TAILORx results define recurrence score ≤25 as chemotherapy-sparing","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2020-12","type":"label-change","region":"US","note":"RxPONDER extends to 1-3 positive nodes (postmenopausal)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"}]},"route":"/drugs/oncotype-dx/","neighbours":{"drug":[{"id":"breast-cancer-index","kind":"drug","name":"Breast Cancer Index","route":"/drugs/breast-cancer-index/"},{"id":"endopredict","kind":"drug","name":"EndoPredict","route":"/drugs/endopredict/"},{"id":"mammaprint","kind":"drug","name":"MammaPrint (70-gene signature)","route":"/drugs/mammaprint/"},{"id":"prosigna","kind":"drug","name":"Prosigna (PAM50)","route":"/drugs/prosigna/"}],"pairing":[{"id":"genomic-assay-to-chemo-omission","kind":"pairing","name":"Gene-expression assay → chemotherapy omission","route":"/pairings/genomic-assay-to-chemo-omission/"}],"cancer":[{"id":"ductal-carcinoma-in-situ","kind":"cancer","name":"Ductal carcinoma in situ (DCIS)","route":"/cancers/ductal-carcinoma-in-situ/"},{"id":"hr-positive-early-high-risk","kind":"cancer","name":"High-risk early HR-positive breast cancer","route":"/cancers/hr-positive-early-high-risk/"},{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"},{"id":"invasive-breast-carcinoma-no-special-type","kind":"cancer","name":"Invasive breast carcinoma of no special type (invasive ductal carcinoma)","route":"/cancers/invasive-breast-carcinoma-no-special-type/"}],"technology":[{"id":"companion-diagnostic","kind":"technology","name":"Companion diagnostics","route":"/technologies/companion-diagnostic/"},{"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":"exact-sciences","kind":"company","name":"Exact Sciences (Abbott)","route":"/companies/exact-sciences/"},{"id":"nsabp-foundation","kind":"company","name":"NSABP Foundation","route":"/companies/nsabp-foundation/"}],"trial":[{"id":"rxponder","kind":"trial","name":"RxPONDER (SWOG S1007)","route":"/trials/rxponder/"},{"id":"tailorx","kind":"trial","name":"TAILORx","route":"/trials/tailorx/"}],"person":[{"id":"joseph-sparano","kind":"person","name":"Joseph A. Sparano","route":"/people/joseph-sparano/"},{"id":"kathy-albain","kind":"person","name":"Kathy S. Albain","route":"/people/kathy-albain/"},{"id":"kevin-kalinsky","kind":"person","name":"Kevin Kalinsky","route":"/people/kevin-kalinsky/"}],"idea":[{"id":"idea-tr2-prospective-retrospective-path","kind":"idea","name":"A formal regulatory route for validating a biomarker on archived trial samples","route":"/ideas/idea-tr2-prospective-retrospective-path/"},{"id":"idea-fund-biomarker-validation-fund","kind":"idea","name":"A fund for prospective validation of academic biomarkers and companion diagnostics","route":"/ideas/idea-fund-biomarker-validation-fund/"},{"id":"idea-fund-omission-deescalation-trials","kind":"idea","name":"Payer-funded trials that omit surgery or radiotherapy in low-risk patients","route":"/ideas/idea-fund-omission-deescalation-trials/"}],"term":[{"id":"biomarker-stratified-design","kind":"term","name":"Enrichment and biomarker-stratified designs","route":"/terms/biomarker-stratified-design/"}],"institution":[{"id":"montefiore-einstein","kind":"institution","name":"Montefiore Einstein Comprehensive Cancer Center","route":"/institutions/montefiore-einstein/"},{"id":"emory-winship","kind":"institution","name":"Winship Cancer Institute of Emory University","route":"/institutions/emory-winship/"}],"roadmap":[{"id":"diagnostics-roadmap","kind":"roadmap","name":"Diagnostics roadmap: stains → gene panels → blood tests that decide treatment","route":"/roadmaps/diagnostics-roadmap/"}]}}