Spotlight Medical Gains CE Mark for myStage Dx as an AI-Based Prognostic Test for ER+/HER2- Early Breast Cancer
Shots:
- Spotlight Medical has received CE marking under the EU IVDR for myStage Dx, an AI-enabled prognostic test designed to support risk stratification in patients with ER+/HER2- early breast cancer
- Test analyzes digitized H&E-stained FFPE pathology slides alongside routine clinicopathological variables to generate a binary prognostic classification of Low Risk or Not Low Risk
- In studies across the CANTO & UNIRAD cohorts, myStage Dx identified 19.4% of clinically high-risk pts as Low Risk, with 95.4% remaining free of distant recurrence & breast cancer-related death at 9yrs. vs 76.8% in the Not Low Risk group; data published in the JCO
Ref: Businesswire | Image: Spotlight Medical | Press Release
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