Last updated: 31 August 2026
Please read this notice before using oncobreast21.com or the OncoBreast 21 software. By accessing this website you acknowledge and agree to the terms below.
🔬Research Use Only — not a diagnostic device
OncoBreast 21 is provided for Research Use Only. It is not a medical device, is not CE-marked and not FDA-cleared, and must not be used to inform diagnosis, treatment, or any other clinical decision.
Its outputs are for research, benchmarking, and educational purposes. The software is designed to support — not replace the judgement of qualified professionals; it does not itself make clinical or treatment decisions.
🩺Intended users & responsibility
OncoBreast 21 is intended for researchers and qualified clinicians evaluating a transparent reimplementation of the published 21-gene recurrence-score methodology.
Any interpretation of its output must be verified independently. Nothing on this website creates a doctor–patient relationship, and the responsibility for any clinical decision remains solely with the treating professional.
This website is not directed at patients seeking medical advice; patients should consult their own physician.
🧬What OncoBreast 21 is
OncoBreast 21 is a transparent, deterministic reimplementation of the published 21-gene breast-cancer recurrence-score methodology — with no machine learning in the score — offered as one signal within a longitudinal breast-cancer digital-twin research model. It is version-locked and content-hash audited, and has been externally validated across nine independent public cohorts. Any comparison to established assays is made solely for scientific benchmarking and interoperability, and does not imply equivalence, substitution, or endorsement.
™️Intellectual property & trademark attribution
“Oncotype DX”, “Breast Recurrence Score”, and “Recurrence Score” are registered trademarks of Genomic Health, Inc. / Exact Sciences Corporation.
aumics Oy and the OncoBreast 21 project are independent and are not affiliated with, sponsored by, licensed by, or endorsed by Genomic Health, Inc., Exact Sciences Corporation, or any of their subsidiaries.
All third-party study references (e.g., TAILORx, RxPONDER) and trademark terms are used strictly under the doctrine of Nominative Fair Use for scientific reference and benchmarking.
📋Regulatory status
- European Union: provided for Research Use Only. Not CE-marked; an EU IVDR technical file is in preparation.
- United States: no FDA clearance; not for clinical use.
External validation to date is on public microarray and RNA-seq cohorts; an independent clinical-cohort (FFPE RT-qPCR) validation is planned. Absolute scores should be interpreted in the context of these limitations and any local calibration.
🔒Data & privacy
This website collects only the limited information you choose to submit through its contact form (name, email, and message). It does not collect patient or health data. For full details of what we collect, why, and your rights under the GDPR, see our Privacy Policy.
⚠️Limitation of liability
To the maximum extent permitted by law, aumics Oy disclaims all warranties, express or implied, regarding the accuracy, completeness, or fitness for a particular purpose of any output. It shall not be liable for any decision, outcome, or damages arising from use of, or reliance on, this website or software.
Questions about this notice? Contact oncobreast21@gmail.com.