OnCo
drugsProductEstablished

Oncotype DX

A 21-gene test that tells most women with early hormone-positive breast cancer whether they can safely skip chemotherapy.

TAILORx (2018): women with recurrence score ≤25 (and >50 years) derive no chemotherapy benefit. RxPONDER extended this to 1-3 positive nodes in postmenopausal women. Exact Sciences. MammaPrint (Agendia) and Prosigna/PAM50 are alternatives.

Schematic of the modality · Gene-expression prognostic/predictive assay · not a molecule; see the RNA sequencing & expression profiling page
Mechanism, step by step
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1.RNA is extracted from the tumour block

Modality
Gene-expression prognostic/predictive assay
Mechanism
RT-PCR of 16 cancer and 5 reference genes into a recurrence score.

Regulatory

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  1. Jan 2004Filing / dealUS

    Launched as a laboratory-developed test source

  2. 3 Jun 2018Label changeUS

    TAILORx results define recurrence score ≤25 as chemotherapy-sparing source

  3. Dec 2020Label changeUS

    RxPONDER extends to 1-3 positive nodes (postmenopausal) source

Cost & access

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Cost & access
CountryReimbursement
United StatesMedicare and most commercial plans for node-negative and node-positive (1-3) HR+/HER2- early breast cancer
United KingdomNICE: recommended for ER+/HER2- node-negative and some node-positive early breast cancer (DG58)

List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.

Trials

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
10 studies4 recruiting7 Phase 23 Phase 3
Search “Oncotype DX” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Oncotype DX
intervention: Oncotype DX
Open on ClinicalTrials.gov →

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Latest papers

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Literature trend121 papers in the last 12 months+33% vs prior 12How this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

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.

Connected

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