SimBioSys took a 510(k) for TumorSight Risk, software that estimates breast cancer recurrence risk from a breast MRI the patient has already had. The Chicago company announced the clearance on October 15. The indication covers adult women with hormone receptor positive, HER2 negative Stage I to IIIA disease.
The software reads routine MRI, pathology and clinical inputs, then returns a score from 0 to 100 and a high, intermediate or low category for recurrence-free survival at five and ten years. Validation used 2,129 retrospective patients from Mayo Clinic, Emory University, Stanford Medicine and Mercy Medical Cedar Rapids. High-risk patients recurred at 3.3 times the rate of low-risk patients. The results were presented at ASCO this year, and SimBioSys disclosed that Mayo Clinic holds a financial interest in the research.
Nothing has to leave the clinic, which is the commercial argument against the genomic assays used in the same decision. Those need tissue shipped to a central lab and a turnaround measured in weeks. TumorSight Risk sits on the cleared TumorSight Viz platform, so the predicate and much of the software documentation were already on file.