TumorSight Risk is FDA-cleared. What does its score mean?

SimBioSys announced TumorSight Risk on 15 October, after the FDA cleared it on 25 September (K260023). The software combines pre-treatment contrast-enhanced breast MRI with age, race, stage, nodal status and grade to estimate recurrence risk at five and ten years. Its cleared use is limited to adult women with HR-positive, HER2-negative, stage I–IIIA breast cancer and N0 or N1 nodes. It informs a physician alongside other clinical factors; it does not select treatment.

The FDA file describes a retrospective validation in 2,129 patients at four US sites. Observed five-year recurrence was 2.2% in the lowest score band (515 patients) and 13.6% in the highest (218 patients); these are group estimates, not anyone's personal prognosis. This supports risk stratification, but a retrospective study and 510(k) clearance do not show that using the score improves survival or changes treatment safely.

TumorSight Risk uses imaging and clinical data through a company-operated product; the checked product page gives no public price or source-code licence. OpenOnco instead offers a free browser workflow and MIT-licensed, source-linked rules for reviewing oncology pathways. Its public rules can be inspected and challenged, but OpenOnco cannot read MRI scans or calculate this recurrence score, and has no comparable FDA clearance or head-to-head outcomes evidence. The tools may complement a clinical discussion. Sources and comparison checked 19 October 2026. This article does not replace a qualified physician.