The U.S. Food and Drug Administration (FDA) cleared SimBioSys, Inc.’s TumorSight Risk software to estimate five- and 10-year breast cancer recurrence risk for clinicians treating a defined patient group.
The FDA database records a “Substantially Equivalent” decision dated Sept. 25, 2026. SimBioSys announced the clearance on Oct. 15. The decision came through the 510(k) pathway, which compares a device with a legally marketed product; the FDA filing names ArteraAI Breast as the predicate device.
The prescription software is intended for adult women with hormone receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative) Stage I-IIIA breast cancer and N0 or N1 lymph-node status. It combines dynamic contrast-enhanced MRI data with age, race, cancer stage, lymph-node status and tumor grade. The output is a score from zero to 100 and a low-, intermediate- or high-risk classification. The FDA says clinicians should consider the results alongside other clinical and pathology information.
The FDA-posted summary describes a retrospective validation study of 2,129 patients at four U.S. sites. Patients were diagnosed from Jan. 1, 2010, through Dec. 31, 2024, and had a pretreatment MRI. Estimated recurrence risk for low-, intermediate- and high-risk groups was 3.0%, 5.7% and 9.8%, respectively, at five years, and 8.6%, 13.4% and 26.4% at 10 years.
A separate 2026 American Society of Clinical Oncology meeting abstract, published in the Journal of Clinical Oncology, analyzed scores using a prespecified cutoff of 47 or higher. It classified 1,808 patients as low risk and 321 as high risk, reporting an unadjusted hazard ratio of 2.71 for recurrence-free survival (95% confidence interval: 1.95-3.76; p=3×10⁻⁹). The abstract also reported a 22% increase in relative recurrence risk for each 10-point score increase. The association with recurrence-free survival remained after adjustment for pathologic tumor and lymph-node stage, grade, age, race and treatment (p=0.002). Median follow-up was 6.24 years.
The abstract names SimBioSys as the study sponsor. The company disclosed that Mayo Clinic has a financial interest in SimBioSys. Because the FDA validation was retrospective, it shows how scores aligned with past recurrence; it does not establish whether using the software changes treatment decisions or patient outcomes.
