- Caris Life Sciences (CAI, Financial) releases a groundbreaking study validating the Caris Assure® blood-based biopsy assay.
- The platform achieves 83.1% to 95.7% sensitivity across cancer stages I-IV with 99.6% specificity for early cancer detection.
- Caris Assure® demonstrates significant predictive power for recurrence monitoring with a hazard ratio of 33.4 for MRD.
Caris Life Sciences (CAI) has announced a landmark study validating its Caris Assure® blood-based biopsy assay, published in Scientific Reports. The platform represents a significant leap in liquid biopsy technology, combining whole exome sequencing and whole transcriptome sequencing with advanced AI to analyze over 23,000 genes from both plasma and buffy coat samples.
The study showed that Caris Assure® achieved between 83.1% and 95.7% sensitivity across cancer stages I-IV, coupled with an impressive 99.6% specificity for Multi-Cancer Early Detection (MCED). This high level of accuracy positions the assay as a potent tool for early cancer detection.
Significantly, the platform demonstrated strong predictive capabilities for monitoring recurrence, with a hazard ratio of 33.4 (p < 0.005) for minimal residual disease (MRD) and 4.39 (p = 0.008) for therapeutic monitoring. These metrics underscore Caris Assure®'s potential as a comprehensive cancer management tool.
Caris Assure® is currently available for therapy selection in advanced cancers. However, the company is actively pursuing regulatory approvals to expand into early detection, MRD, and therapeutic monitoring applications. The assay's design eliminates the need for prior tissue biopsies, facilitating a tissue-agnostic approach that enhances accessibility and reduces invasive procedures.
David Spetzler, President of Caris, highlighted that Caris Assure® offers a comprehensive individualized picture of a patient's disease state, integrating advanced sequencing and computing technologies for improved cancer care decisions.
