SimBioSys wins FDA clearance for AI breast cancer recurrence risk tool

What TumorSight Risk does

According to SimBioSys, the software is intended for adult women with hormone receptor-positive (HR+), HER2-negative Stage I, IIIA breast cancer. The company says this subtype represents approximately 75 percent of all breast cancers in the U.S. The tool is meant as a prognostic indicator of recurrence-free survival at five and ten years, and its result should be considered alongside other relevant clinicopathologic factors when assessing risk and planning care.

TumorSight Risk is built on the FDA-cleared TumorSight Viz foundation. It applies proprietary spatial AI modeling to tumor characteristics, surrounding tissue context and clinical factors. The cloud-based platform produces a proprietary score from zero to 100 and a categorical high-, intermediate- or low-risk classification.

The company states that the software uses data already collected as part of routine care and requires no additional procedure, tissue shipment or specialized hardware. It is designed to make results available within standard clinical workflows, and SimBioSys says the insight can be available before surgery to support treatment planning.

Validation study results

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. The results were recently presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. According to the company, the study found that the tool stratified patients by recurrence-free survival:

• Risk-group separation: patients classified as high risk had a 3.3-fold greater risk of recurrence than those classified as low risk.
• Score-response relationship: each 10-point increase in the 0, 100 score was associated with a 22 percent increase in relative recurrence risk.
• Five- and ten-year differentiation: estimated five-year recurrence risk ranged from 2.2 percent for the lowest scores (0, 10) to 13.6 percent for the highest scores (58, 100). At ten years, the range was 6.2 percent to 34.2 percent across the same score groups.
• Independent prognostic value: the score remained significantly associated with recurrence-free survival after adjustment for pathologic tumor and nodal stage, grade, age, race and treatment (p=0.002).

The release notes that Mayo Clinic has a financial interest with SimBioSys and points readers to the study for a full list of disclosures.

Where it fits in current practice

SimBioSys says current recurrence-risk assessment often depends on clinicopathologic features and tissue-based genomic assays. These have advanced care, the company notes, but genomic testing may introduce cost, logistical requirements and turnaround time. 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 available earlier in the care pathway. The company says the added information may help clinicians and patients weigh options such as chemotherapy and whether to continue endocrine therapy beyond five years, alongside potential side effects, quality of life and patient preferences.

Matthew Goetz, M.D., of Mayo Clinic Rochester, said the validation data show that "MRI-derived assessments may provide prognostic information beyond standard clinicopathologic factors." He added that building on information already available in the diagnostic pathway "could offer oncologists a practical new way to refine risk assessment."

What it means for the platform

SimBioSys President and CEO Stacey Stevens said the product expands the TumorSight platform "from surgical visualization into prognostic intelligence." The company plans to work with oncology teams to bring the tool into use for patients nationwide. The release does not give pricing or availability details.