SimBioSys announced on October 15, 2026 that the U.S. Food and Drug Administration has granted 510(k) clearance for TumorSight Risk, an AI-powered software tool that analyzes routinely collected breast MRI, pathology, and clinical data to generate individualized five- and ten-year recurrence risk estimates. The tool is indicated for adult women with hormone receptor-positive (HR+), HER2-negative Stage I–IIIA breast cancer, a subtype the company says accounts for approximately 75 percent of all breast cancers in the United States.
The FDA clearance was supported by a blinded, prospectively-designed retrospective, multi-institutional validation study of 2,129 patients. The results were presented at the 2026 American Society of Clinical Oncology Annual Meeting. The study showed that TumorSight Risk stratified patients by recurrence-free survival, independent of standard clinicopathologic factors. Though the tool is intended to complement and not replace existing prognostic approaches, results should be considered alongside other relevant clinical and pathologic information.
Key finding
In a 2,129-patient multi-institutional validation study, patients classified as high risk by TumorSight Risk had a 3.3-fold greater risk of recurrence than those classified as low risk, and the score remained independently prognostic after adjustment for standard clinicopathologic factors (p=0.002); however, the study was a retrospective analysis and prospective outcome data have not yet been reported.
Study Design
| Trial | Blinded, prospectively-designed retrospective, multi-institutional validation study supporting FDA 510(k) clearance of TumorSight Risk; results presented at the 2026 ASCO Annual Meeting |
|---|---|
| Population | 2,129 adult women with HR-positive, HER2-negative Stage I–IIIA breast cancer; data drawn from Mayo Clinic, Emory University, Stanford Medicine, and Mercy Medical Cedar Rapids |
| Primary endpoint | Recurrence-free survival stratification by TumorSight Risk score and risk categories high, intermediate, and low |
| Key secondary endpoints | Independent prognostic value of the TumorSight Risk score after adjustment for pathologic tumor and nodal stage, grade, age, race, and treatment; score-response relationship across the 0–100 scale |
This validation study used a prospective statistical analysis plan applied to retrospectively collected data from four academic and community institutions. No additional procedures, tissue shipments, or specialized hardware were required; the tool analyzed MRI, pathology, and clinical information already collected as part of routine care. A treatment row is omitted from the table above because the study evaluated prognostic performance across patients who received varied standard-of-care treatments rather than a single assigned intervention.
Results
TumorSight Risk successfully separated patients by recurrence-free survival across its three risk categories. Patients classified as high risk had a 3.3-fold greater risk of recurrence compared with those classified as low risk. Each 10-point increase in the 0–100 proprietary score was associated with a 22 percent increase in relative recurrence risk. Estimated five-year recurrence risk ranged from 2.2 percent among patients with the lowest scores (0–10) to 13.6 percent among those with the highest scores (58–100); at ten years, the corresponding range was 6.2 percent to 34.2 percent.
The score retained statistically significant independent prognostic value after adjustment for pathologic tumor and nodal stage, grade, age, race, and treatment (p=0.002), indicating that the MRI-derived signal captures information beyond what is available from standard clinicopathologic factors alone.
Clinical Context
Current recurrence risk assessment in HR-positive, HER2-negative early-stage breast cancer relies primarily on clinicopathologic features and tissue-based genomic assays such as multigene expression tests. While genomic testing has meaningfully advanced individualized treatment decisions, it can introduce added cost, logistical requirements, longer turnaround times, and validated options have historically been more limited for certain patient groups, including premenopausal women and those with lymph node-positive disease. TumorSight Risk is positioned as a complementary, imaging-native approach that can be available before surgery and does not require a separate tissue sample or laboratory workflow.
SimBioSys and study investigators suggest the tool could help inform decisions around chemotherapy use and extended endocrine therapy, though the announcement did not present prospective interventional data linking TumorSight Risk-guided treatment changes to improved patient outcomes. Whether incorporation of the score into clinical decision-making translates to measurable benefit in survival or quality of life remains to be established in prospective studies.
Sources
- SimBioSys. “SimBioSys Secures FDA Clearance for TumorSight Risk, Introducing the World’s First AI-Powered MRI-Derived Breast Cancer Recurrence Risk Assessment.” Press release. October 15, 2026. View source.
