FDA-cleared TumorSight Risk estimates breast cancer recurrence

TumorSight Risk is intended for adult women with HR-positive, HER2-negative Stage I–IIIA breast cancer, whether their lymph nodes are negative or positive.[1] It uses clinical information and dynamic contrast-enhanced MRI data to estimate recurrence risk at five and 10 years and generate a prognostic score.[1] The tool assesses recurrence risk using data from patients already diagnosed with invasive breast cancer.[1] SimBioSys describes the score as a proprietary scale from zero to 100 that places patients in high-, intermediate- or low-risk groups.[2]

The validation study was blinded, prospectively designed, retrospective and multi-institutional, with 2,129 patients from four health systems.[2] Its results were presented at the 2026 American Society of Clinical Oncology Annual Meeting.[2] In the study, the high-risk group had 3.3 times the recurrence risk of the low-risk group, and each 10-point increase in score was associated with a 22% increase in relative recurrence risk.[2] Estimated five-year recurrence risk ranged from 2.2% for scores of 0–10 to 13.6% for scores of 58–100; estimated 10-year risk in those groups ranged from 6.2% to 34.2%.[2]

The score remained significantly associated with recurrence-free survival after adjustment for standard prognostic information, with p=0.002.[2] ABC News reported that 95.5% of low-risk patients remained cancer-free after five years, compared with 89.6% of high-risk patients.[3] These results describe risk differences in the study; they do not establish that using the tool changes treatment outcomes.[2][3] SimBioSys says physicians should consider the assessment alongside other relevant clinicopathologic factors when assessing risk and planning care.[2]

SimBioSys says TumorSight Risk analyzes information already collected in routine care and requires no additional procedure, tissue shipment or specialized hardware.[2] The company describes it as cloud-based and says results may be available before surgery.[2] SimBioSys says the additional risk information may help clinicians and patients weigh chemotherapy and whether to continue endocrine therapy beyond five years.[2] ABC News reports the software is starting to be used in hospitals and cancer centers nationwide, while the company works with Medicare, Medicaid and private insurers to obtain coverage.[3]