For Research Use Only · Not for use in diagnostic procedures.
A deterministic breast-cancer digital twin

One patient. One continuous record. One living model.

OncoBreast21 is a transparent, deterministic digital twin for breast cancer — the published 21-gene recurrence score at its core, extended across the disease journey into one auditable, longitudinal model. No machine learning in the score; externally validated across nine independent public cohorts. Built for researchers and clinicians who need an auditable engine, not a black box.

Nine cohorts · Cohen’s κ 0.94 · C-index matched to reference — reproducible & auditable.

For Research Use Only — not a diagnostic device. Intended for research, not for guiding patient treatment.

Expression Scoring 21-gene recurrence-risk score Hereditary Mutations Germline BRCA1/2 & panel genes Pharmacogenomics Drug–gene safety & dosing Signals · one record
21-gene recurrence-score scale one clear result
Lower riskHigher risk
Low Intermediate High
Evidence

Reproducible, and externally validated

OncoBreast21 reproduces the published 21-gene recurrence score deterministically. Against an independent reference implementation across nine public cohorts (~5,488 patients): near-perfect agreement, and a Harrell C-index that matches the reference in every cohort with a survival endpoint.

Agreement

Cohen’s κ 0.94

Risk-band assignment agrees with an independent implementation of the published formula on the same patients (Spearman up to 0.998).

Discrimination

C-index matched

Harrell C-index matches the reference implementation in every cohort carrying a survival endpoint.

Transparency

Deterministic · no ML

Version-locked and content-hash-audited; recalibratable to a local population. Methods and manuscript available on request.

Method

A transparent, deterministic engine

The published 21-gene methodology, computed exactly and reproducibly — every number is traceable to its inputs.

Reference normalisation

Expression is normalised to the reference genes exactly as specified; QC gates fail unusable inputs safely.

Group scores

Proliferation, invasion, HER2 and ER group scores are combined using the published coefficients.

Deterministic score & band

A single unscaled value maps through the fixed scale to a Low / Intermediate / High band — no machine learning.

Version-locked & auditable

The configuration is content-hash-stamped and drift-guarded, so a given input always yields the same result.

Intended use

Where the engine applies

For Research Use Only. The recurrence-score module addresses one clearly-defined population.

✓ In scope

  • Hormone-receptor-positive (ER-positive)
  • HER2-negative
  • Early-stage, invasive
  • Node-negative, or 1–3 positive nodes

✗ Out of scope

  • HER2-positive disease
  • Triple-negative disease
  • Non-invasive changes (DCIS / LCIS only)
  • Advanced, inflammatory, or male breast cancer
Approach & status

Anchored to a method used worldwide

OncoBreast21 reconstructs the 21-gene methodology studied in large clinical trials (TAILORx, RxPONDER). External validation to date is on public array and RNA-seq cohorts; an independent clinical-cohort validation (FFPE RT-qPCR) is planned.

Method

Established & published

A well-studied way of reading tumour genes to estimate distant-recurrence risk.

Human-in-the-loop

Decision-support only

Advisory to the clinician and tumour board — it does not diagnose or decide.

Open

Evidence on request

Validation summary, methods and manuscript draft available to researchers and clinicians.

What OncoBreast21 is — and isn’t

Stated plainly

OncoBreast21 is a transparent reconstruction of the 21-gene recurrence score, for research use. It is not a diagnostic device, it does not make treatment decisions, and it is not CE-marked or FDA-cleared.

Research Use Only. Not for use in diagnostic procedures; the treating clinician makes every decision.
Grounded in established science. The recurrence-score module reconstructs a method studied in large clinical trials (TAILORx, RxPONDER).
Externally validated. Nine public cohorts; an independent clinical-cohort (FFPE RT-qPCR) validation is planned.
Transparent by design. Deterministic, version-locked, content-hash-audited — no machine learning in the score.

For researchers & clinicians

Request the validation summary and methods, or discuss a research collaboration.

Contact the team