Company Announcements

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.

"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."

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.

"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."

About Caris Life Sciences 
Caris Life Sciences ^® (Caris) 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 (Whole Exome and Whole Transcriptome Sequencing) 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. This convergence of next-generation sequencing, AI and machine learning technologies, and high-performance computing provides a differentiated platform to develop the latest generation of advanced precision medicine diagnostic solutions for early detection, diagnosis, monitoring, therapy selection and drug development.

Caris was founded with the belief and vision that combining a vast set of consistently generated molecular information with robust data-driven insights could realize the potential of precision medicine for patients. 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.

The Scientific Report study is available on CarisLifeSciences.com.

Forward Looking Statements:
This press release contains forward-looking statements, within the meaning of the federal securities laws, about Caris Life Sciences and its business. Statements about the performance and accuracy of Caris Assure discussed in this press release are based on testing and analysis to date, as reflected in the publication discussed, and future results and performance may differ materially from these findings. All statements other than statements of historical facts contained in this press release are forward-looking statements. In some cases forward-looking statements can be identified by words such as "may," "will," "should," "would," "expect," "plan," "anticipate," "could," "intend," "target," "project," "potential," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or similar expressions.

You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in these forward-looking statements are reasonable based on information currently available to us, we cannot guarantee that the future results, discoveries, levels of activity, performance or events and circumstances reflected in forward-looking statements will be achieved or occur. Forward-looking statements involve known and unknown risks and uncertainties, some of which are beyond our control. Risks and uncertainties that could cause our actual results to differ materially from those indicated or implied by the forward-looking statements in this press release include, among other things: developments in the precision oncology industry; future financial performance, results of operations or other operational results or metrics; development, validation and timing of future solutions; the rapidly evolving competitive environment in which we operate; third-party payer reimbursement and coverage decisions; our ability to protect and enhance our intellectual property; regulatory requirements, decisions or approvals (including the timing and conditions thereof) related to our solutions; our compliance with laws and regulations; and our ability to hire and retain key personnel as well as risks, uncertainties, and other factors described in the section titled "Risk Factors" and elsewhere in the prospectus for our initial public offering filed with the Securities and Exchange Commission on June 20, 2025, and in our other filings we make with the SEC from time to time. We undertake no obligation to update any forward-looking statements to reflect changes in events, circumstances or our beliefs after the date of this press release, except as required by law.

Caris Life Sciences Media:
Corporate Communications
CorpComm@CarisLS.com
214.294.5606

Investor Relations:
Narendra Chokshi
Senior Vice President, Corporate Development
nchokshi@carisls.com
917.689.3511

View original content to download multimedia:https://www.prnewswire.com/news-releases/caris-life-sciences-announces-new-study-demonstrating-the-power-and-clinical-utility-of-its-caris-assure-blood-based-assay-for-multi-cancer-early-detection-minimal-residual-disease-and-therapy-selection-302499499.html

SOURCE Caris Life Sciences