Caris Life Sciences Announces New Study Demonstrating Accuracy And Clinical Utility Of Caris Assure Blood-Based Biopsy Assay Across Cancer Continuum

Scientific Reports study validates the first multifunctional, AI-enabled blood-based assay to offer diagnostic, prognostic and predictive utility in a single assay.

IRVING, Texas, July 8, 2025 /PRNewswire/ -- Caris Life Sciences® (NASDAQ:CAI), a leading, patient-centric, next-generation AI TechBio company and precision medicine pioneer, announced a landmark study published in Scientific Reports, a Nature journal, demonstrating the accuracy and clinical utility of the Caris Assure® blood-based biopsy assay across the cancer continuum.

The Caris Assure® platform is a breakthrough single assay that combines comprehensive, highly sophisticated molecular profiling of all 23,000+ genes across DNA and RNA in plasma, setting a new blood-based testing standard and revolutionizing management of the cancer care journey. Additionally, Caris sequences DNA in the "buffy coat," the layer of centrifuged blood between the red blood cells and plasma, which contains white blood cells and platelets. Caris Assure combines Whole Exome Sequencing (WES) and Whole Transcriptome Sequencing (WTS) with advanced machine learning on a single platform. Caris Assure® is currently used for therapy selection and is capable of enabling accurate early detection and highly sensitive disease monitoring.

The Caris Assure® liquid biopsy platform, powered by the Assure Blood-based Cancer Detection AI (ABCDai), was trained on over 376,000 whole exome and whole transcriptome tissue profiles and over 7,000 matched blood and tissue samples. In addition to therapy selection, the study validates the performance of Caris Assure® in:

• Multi-Cancer Early Detection (MCED): Achieved sensitivities of 83.1% to 95.7% across cancer stages I–IV at 99.6% specificity.
• Diagnostic Pathway Predictor: Accurately identified the diagnostic pathway for MCED-positive cancers using the ABCDai-GPS model.
• MRD and Recurrence Monitoring: Demonstrated significant predictive power for recurrence, with hazard ratios of 33.4 (p < 0.005) for MRD and 4.39 (p = 0.008) for therapeutic monitoring.

Caris Assure® does not require a prior tissue biopsy. Instead, its AI model identifies tumor-derived signals based on patterns learned from hundreds of thousands of tumors. This enables a tissue-agnostic, highly sensitive approach to cancer detection and monitoring.

While Caris Assure® is currently commercially available for therapy selection in advanced cancers, this study lays the groundwork for expanding into early detection, MRD and therapeutic monitoring. Caris is actively pursuing reimbursement and regulatory pathways to bring these applications to market.