On October 15, 2026 SimBioSys, an AI-driven precision medicine company revolutionizing how cancer is understood and treated, reported U.S. Food and Drug Administration (FDA) 510(k) clearance of TumorSight Risk, the world’s first AI-powered, MRI-derived prognostic tool for assessing breast cancer recurrence risk. The software analyzes routinely collected breast MRI, pathology and clinical data to generate an individualized prognosis at five and ten years, giving oncologists objective insight that can be available before surgery to support treatment planning for women with hormone receptor-positive (HR+), HER2-negative Stage I–IIIA breast cancer—a subtype representing approximately 75 percent of all breast cancers in the U.S.
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"Achieving FDA clearance of TumorSight Risk marks a defining moment for SimBioSys and for precision breast cancer care," said Stacey Stevens, President and CEO of SimBioSys. "For the first time, clinicians can use the rich biological and spatial information already captured in a patient’s breast MRI—together with standard pathology and clinical factors—to gain personalized insight into recurrence risk. By delivering this intelligence rapidly within the existing care pathway, TumorSight Risk has the potential to expand access to prognostic information and help clinicians and patients approach treatment decisions with greater clarity and confidence."
Built on the FDA-cleared TumorSight Viz foundation, TumorSight Risk applies proprietary spatial AI modeling to tumor characteristics, surrounding tissue context, and clinical factors. The cloud-based software platform produces a proprietary score from zero to 100 and a categorical high-, intermediate- or low-risk classification. It uses data already collected as part of routine care, requires no additional procedure, tissue shipment, or specialized hardware, and is designed to make results available within standard clinical workflows.
TumorSight Risk is intended for use as a prognostic indicator of recurrence-free survival at five and ten years in adult women with HR-positive, HER2-negative Stage I–IIIA breast cancer. The result should be considered alongside other relevant clinicopathologic factors when assessing risk and planning care.
The clearance is supported by a blinded, prospectively-designed retrospective, multi-institutional validation study of 2,129 patients from Mayo Clinic, Emory University, Stanford Medicine and Mercy Medical Cedar Rapids. Results were recently presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.1 The study found that TumorSight Risk successfully stratified patients by recurrence-free survival:
Clear risk-group separation — Patients classified as high risk had a 3.3-fold greater risk of recurrence than those classified as low risk.
Strong score-response relationship — Each 10-point increase in the 0–100 score was associated with a 22 percent increase in relative recurrence risk.
Meaningful five- and ten-year differentiation — Estimated five-year recurrence risk ranged from 2.2 percent for patients with the lowest scores (0–10) to 13.6 percent for those with the highest scores (58–100). At ten years, estimated recurrence risk ranged from 6.2 percent to 34.2 percent across those same score groups.
Independent prognostic value — The score remained significantly associated with recurrence-free survival after adjustment for standard of care prognostic information including pathologic tumor and nodal stage, grade, age, race and treatment (p=0.002).
"Accurately defining recurrence risk is central to individualizing treatment for patients with early stage, hormone receptor-positive breast cancer," said Matthew Goetz, M.D., the Erivan K. Haub Family Professor of Cancer Research Honoring Richard F. Emslander, M.D. Enterprise Deputy Director, Translational Research and Director: Mayo Breast Cancer SPORE Mayo Clinic Rochester. "The multi-institutional validation data show that MRI-derived assessments may provide prognostic information beyond standard clinicopathologic factors. The ability to build on information already available in the diagnostic pathway could offer oncologists a practical new way to refine risk assessment and support more informed conversations with patients."
Current recurrence-risk assessment often depends on clinicopathologic features and tissue-based genomic assays. Although these approaches have advanced care, genomic testing may introduce cost, logistical requirements and turnaround time, and some patient groups—including premenopausal and lymph node-positive women—have historically had fewer validated options. TumorSight Risk is designed to complement existing methods with an imaging-native assessment that is available earlier in the care pathway and applicable across a broad population of patients with HR-positive, HER2-negative early-stage disease. That additional insight may help clinicians and patients weigh treatment options—including chemotherapy and whether to continue endocrine therapy beyond five years—alongside potential side effects, quality of life and patient preferences.
"TumorSight Risk expands the TumorSight platform from surgical visualization into prognostic intelligence, bringing us closer to a connected, patient-specific view of cancer across the continuum of care," added Ms. Stevens. "This world-first clearance demonstrates what becomes possible when imaging, biology and AI are brought together in a clinically meaningful way. We look forward to working with oncology teams to translate this advancement into more individualized care for patients nationwide."
(Press release, SimBioSys, OCT 15, 2026, View Source [SID1234673501])