SimBioSys Secures FDA Clearance for AI Breast Cancer Tool

CHICAGO, Oct. 15, 2026 /CourierPR/ -- SimBioSys, an AI-driven precision medicine company revolutionizing how cancer is understood and treated, today announced 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, providing oncologists with objective insight that can be available before surgery to support treatment planning for women with hormone receptor-positive (HR+) and HER2-negative Stage I, IIIA breast cancer, a subtype representing approximately 75 percent of all breast cancers in the U.S.

The clearance of TumorSight® Risk marks a defining moment for SimBioSys and for precision breast cancer care. 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 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) Annual Meeting. 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).

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.