The evidence, in full

Digistain’s published evidence, with the limitations the authors state.

Digistain publications

Publication	What it reports
Coombes et al. Performance of a novel spectroscopy-based tool for adjuvant therapy decision-making in hormone receptor-positive breast cancer: a validation study. Breast Cancer Research and Treatment 2024;205:349–358. Read the paper	Peer-reviewed validation in 801 patients with HR-positive, HER2-negative breast cancer and 0–3 positive nodes, treated with endocrine therapy without chemotherapy. Median follow-up 12.7 years (range 0.9–19 years).
ESMO Breast 2023 abstract. Association of the Digistain Prognostic Score with outcomes in patients with HR-positive HER2-negative breast cancer. [LINK]	Outcome associations in the same 801-patient cohort, including AUC and negative predictive value at 5 and 10 years.
SABCS 2024 poster P1-11-27. [TITLE AND LINK]	[APPROVED SUMMARY PENDING REGULATORY SIGN-OFF]

Retrospective, single centre: Nottingham City Hospital, patients treated 1998–2006. The authors note this is somewhat atypical of a contemporary population.
Validation used K-fold cross-validation within the same institution, not an independent external cohort. Multicentre studies are reported as in progress.
Low-risk cohort by design: 90% had no recurrence within 10 years. Positive predictive value is low (0.02–0.09 at 5 years), as expected for a rule-out test.
The authors conclude performance is similar to that reported for other risk tools.
Declared interest: Hemmel Amrania and Chris Phillips are Digistain’s CEO and CSO.

Hieronymus H, et al. Tumor copy number alteration burden is a pan-cancer prognostic factor associated with recurrence and death. eLife 2018. [LINK]