Caris Detect Study Shows 56.8% Stage I Sensitivity, 99.2% Specificity
Caris Life Sciences reported finalized Achieve 1 results for Caris Detect in 3,014 high-risk subjects, achieving 56.8% sensitivity in Stage I, 67.7% in Stage II and 98.6% in Stage IV cancers. The assay delivered 99.2% specificity in asymptomatic individuals and 96.0% specificity in benign or high-risk subjects.
1. Study Finalization and Purpose
Caris Life Sciences has completed its Achieve 1 study, marking a critical milestone in the development of Caris Detect, its multi-cancer early detection test. The finalized data transitions the program from interim analysis to a comprehensive performance report across multiple tumor stages.
2. Cohort Composition and Methodology
A total of 3,014 evaluable subjects were enrolled based on high-risk screening, symptomatic presentation or imaging-detected masses. Peripheral blood samples were analyzed using whole genome sequencing to assess diagnostic accuracy across Stage I through IV cancers.
3. Key Sensitivity and Specificity Results
Caris Detect achieved sensitivities of 56.8% in Stage I, 67.7% in Stage II, 79.0% in Stage III and 98.6% in Stage IV cancers. The assay demonstrated 99.2% specificity in asymptomatic individuals and 96.0% specificity in benign or high-risk groups.
4. Next Steps: Additional Pillars and Launch
Following whole genome sequencing validation, Caris plans to integrate Whole Transcriptome Sequencing and other biological pillars to enhance detection performance ahead of Caris Detect’s planned market introduction.