Caris Life Sciences Launches Caris MI Clarity: AI-Powered Test for Breast Cancer Recurrence Risk Prediction
Caris MI Clarity is the first prognostic test designed to predict both early (0-5 years) and late (5-15 years) distant recurrence risk at the time of diagnosis for postmenopausal patients with HR-positive/HER2-negative, node-negative early-stage breast cancer
The test uses AI and machine learning to analyze digitized pathology slides (H&E images) combined with clinical data without requiring genomic sequencing
Results are delivered within 3 business days of receiving the tissue sample, compared to weeks for historical tests
The test was validated through a multi-year collaboration with ECOG-ACRIN Cancer Research Group using data from TAILORx and NSABP B-42 clinical trials
Caris MI Clarity provides distinct risk stratification into Low- or High-risk categories for both early and late recurrence, helping clinicians understand how recurrence risk may evolve over 15 years
Multimodal AI models integrating imaging, clinical, and molecular data demonstrated enhanced prognostic performance compared to existing recurrence-risk assessment methods like Oncotype DX (ODX)
The test launched on May 5, 2026, and represents Caris Life Sciences' continued expansion into advanced AI-driven multimodal risk assessment tools