AI-Enabled Blood Test Demonstrates Diagnostic, Prognostic and Predictive Utility Across Cancer Continuum

Many cancers are diagnosed at advanced stages, limiting treatment options and impacting survival rates. The complexity of cancer, with over 23,000 genes involved, makes it difficult to gain a comprehensive view of the disease from traditional biopsy methods. Additionally, current diagnostic approaches often rely on tissue biopsies, which are invasive and not always feasible for continuous monitoring. To address these issues, a more accurate, non-invasive blood-based test that can detect cancer across its continuum and help monitor disease progression is crucial. Now, a breakthrough approach could revolutionize the management of cancer care by allowing for early detection and highly sensitive monitoring.

Caris Life Sciences (Irving, TX, USA) has introduced Caris Assure, a minimally invasive blood test designed to improve cancer diagnostics and treatment. This assay combines whole exome sequencing (WES) and whole transcriptome sequencing (WTS) with advanced machine learning. By analyzing plasma from blood samples, the test sequences the DNA from white blood cells and the RNA from tumor material circulating in the bloodstream, enabling a comprehensive picture of a patient’s disease state. The assay uses the Assure Blood-based Cancer Detection AI (ABCDai), which was trained on a vast dataset of tissue and blood samples to identify tumor-derived signals. This assay provides a non-invasive, tissue-agnostic method for detecting cancer and monitoring its progression.

Caris Assure has been tested and validated in a landmark study published in Scientific Reports. The study demonstrated its high sensitivity in early cancer detection, with sensitivities ranging from 83.1% to 95.7% across stages I-IV at 99.6% specificity. It also proved effective in predicting minimal residual disease (MRD) and monitoring recurrence, with hazard ratios of 33.4 for MRD and 4.39 for therapeutic monitoring. These findings highlight Caris Assure’s potential in providing accurate, timely information for cancer care, including therapy selection, early detection, and recurrence monitoring. Caris is actively pursuing reimbursement and regulatory pathways to expand its applications for early detection and therapeutic monitoring.

"This is more than a validation study; it is a blueprint for the future of cancer diagnostics," said David Spetzler, MS, PhD, MBA, President of Caris. "Our goal is to create a seamless ecosystem where patients and clinicians can rely on one platform throughout the entire cancer journey."

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