What Happened

SimBioSys received FDA clearance for TumorSight Risk, an AI-powered prognostic tool that uses breast MRI, pathology, and clinical data to assess recurrence risk for HR+, HER2-negative Stage I–IIIA breast cancer. The tool, built on the FDA-cleared TumorSight Viz foundation and powered by Nvidia, applies spatial AI modeling to generate a personalized risk score within one hour.

The clearance is supported by a blinded, prospectively-designed retrospective validation study of 2,129 patients from Mayo Clinic, Emory University, Stanford Medicine, and Mercy Medical Cedar Rapids, with results presented at the 2026 ASCO Annual Meeting.

Who Is Affected

Oncologists treating HR+, HER2-negative early-stage breast cancer patients now have access to a faster, imaging-native recurrence risk assessment. SimBioSys can begin commercializing the tool, targeting the ~75% of US breast cancer patients in this subtype. Current genomic assay providers face a new competitor that delivers results in hours rather than weeks.

Healthcare systems and clinics that already perform breast MRI can integrate TumorSight Risk into their standard workflows without additional hardware or tissue shipment.

Market Impact

• TumorSight Risk addresses a large addressable market: HR+, HER2-negative early-stage breast cancer represents ~75% of US breast cancers.
• Results in one hour versus up to two weeks for tissue-based genomic assays could shift standard of care toward earlier, imaging-based risk stratification.
• The tool complements existing methods and may expand options for premenopausal and lymph node-positive women who have had fewer validated options.
• SimBioSys’s clearance creates partnership and integration opportunities for companies selling into

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