Caris Life Sciences 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 breakthrough platform represents the first multifunctional, AI-enabled blood-based assay to offer diagnostic, prognostic and predictive utility in a single test.
Revolutionary Blood-Based Testing Platform
The Caris Assure platform combines comprehensive, highly sophisticated molecular profiling of all 23,000+ genes across DNA and RNA in plasma, setting a new blood-based testing standard. The assay sequences DNA in the "buffy coat," the layer of centrifuged blood between red blood cells and plasma containing white blood cells and platelets. By combining 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 enables accurate early detection and highly sensitive disease monitoring.
"We designed Caris Assure to be more than a liquid biopsy test. This assay takes advantage of advanced sequencing and computing technology to capture genetic information available from the whole exome and whole transcriptome from the tumor material circulating in the blood and DNA from the patient's white blood cells," said David Spetzler, MS, PhD, MBA, President of Caris. "This enables us to provide a very comprehensive individualized picture of a patient's specific disease state. This is the first time so much molecular information has been available from a single blood test, allowing for increased accuracy and additional insights to inform physicians in helping to make cancer care decisions."
AI Training and Clinical Performance
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. The study validates the performance of Caris Assure in multiple clinical applications beyond therapy selection.
For Multi-Cancer Early Detection (MCED), the platform achieved sensitivities of 83.1% to 95.7% across cancer stages I–IV at 99.6% specificity. The Diagnostic Pathway Predictor accurately identified the diagnostic pathway for MCED-positive cancers using the ABCDai-GPS model.
In MRD and Recurrence Monitoring, the assay 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.
Tissue-Agnostic Approach
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.
"This is more than a validation study; it is a blueprint for the future of cancer diagnostics," added Spetzler. "Our goal is to create a seamless ecosystem where patients and clinicians can rely on one platform throughout the entire cancer journey."
Company Background
Caris Life Sciences is a leading, patient-centric, next-generation AI TechBio company and precision medicine pioneer that is actively developing and commercializing innovative solutions to transform healthcare. Through comprehensive molecular profiling and the application of advanced AI and machine learning algorithms at scale, Caris has created the large-scale, multimodal clinico-genomic database and computing capability needed to analyze and further unravel the molecular complexity of disease.
Headquartered in Irving, Texas, Caris has offices in Phoenix, New York, Cambridge (MA), Tokyo, Japan and Basel, Switzerland. Caris or its distributor partners provide services in the U.S. and other international markets.
