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A 21-gene test that tells most women with early hormone-positive breast cancer whether they can safely skip chemotherapy.
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.
RT-PCR of 16 cancer and 5 reference genes into a recurrence score.
1.RNA is extracted from the tumour block
| Date | Deal | Type | Upfront | Total | Source |
|---|---|---|---|---|---|
| 2025-11 | Exact Sciences (Abbott) to Abbott Cologuard, Oncotype DX, Cancerguard and Oncodetect | Acquisition | not disclosed | $21bn | source |
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | Medicare and most commercial plans for node-negative and node-positive (1-3) HR+/HER2- early breast cancer | ~$4,500 list price | - |
| United Kingdom | NICE: recommended for ER+/HER2- node-negative and some node-positive early breast cancer (DG58) | not disclosed | - |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
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Query for this drug: (TITLE:"Oncotype DX" OR ABSTRACT:"Oncotype DX") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Oncotype DX, not a curated reading list.
Shares MammaPrint (70-gene signature), Enrichment and biomarker-stratified designs, High-risk early HR-positive breast cancer, RNA sequencing & expression profiling.
Shares MammaPrint (70-gene signature), RNA sequencing & expression profiling, HR-positive / HER2-negative breast cancer.
Shares EndoPredict, Companion diagnostics, HR-positive / HER2-negative breast cancer.
Shares A formal regulatory route for validating a biomarker on archived trial samples, A fund for prospective validation of academic biomarkers and companion diagnostics, Companion diagnostics.
Shares Invasive breast carcinoma of no special type (invasive ductal carcinoma), Ductal carcinoma in situ (DCIS), HR-positive / HER2-negative breast cancer.
Shares High-risk early HR-positive breast cancer, Diagnostics roadmap: stains → gene panels → blood tests that decide treatment, HR-positive / HER2-negative breast cancer.
Shares RxPONDER (SWOG S1007), Enrichment and biomarker-stratified designs.