Caris Life Sciences Publishes Study on the Caris Lookback Program Demonstrating the Ongoing Clinical Value of Comprehensive Testing with Caris MI Cancer Seek

The Caris Lookback Program identified 13,293 patients potentially eligible for newly approved targeted therapies across 10 tumor types

IRVING, Texas, May 15, 2026 /PRNewswire/ -- Caris Life Sciences® (NASDAQ:CAI), a leading, patient-centric, next-generation AI TechBio company and precision medicine pioneer, today announced the publication of a Caris‑led study in The Oncologist demonstrating the ability of the Caris Lookback Program to proactively identify previously-profiled patients who become eligible for newly approved targeted therapies.

Molecular profiling reports from most labs are static, reflecting clinical knowledge only at the time of testing. As new biomarker–drug associations and therapeutic indications emerge, patients with previously identified biomarkers may miss newly approved treatment opportunities, while clinicians face increasing challenges staying current with evolving evidence.

Since 2014, Caris patients have benefited from the dynamic Caris Lookback Program, which addresses limitations of static molecular profiling reports. Through this program, Caris continuously monitors new FDA approvals and guideline updates regarding biomarker‑linked therapies.  When new clinical actionability is identified, Caris retrospectively reviews prior patient test results to identify those patients whose molecular profiles align with the new or updated recommendations, all without the need for additional testing. Treating oncologists are then proactively notified through coordinated Medical Affairs and Molecular Science Liaison (MSL) outreach. Caris patients can therefore benefit long after testing has occurred and oncologists can benefit from updated therapeutic insights.

"As the number of biomarker‑driven therapies continues to accelerate, a static analysis limited to a single moment‑in‑time is no longer sufficient in many cases," said James Hamrick, MD, MPH, Chairman, Caris Precision Oncology Alliance. "The Caris Lookback Program was designed to extend the clinical value of comprehensive molecular profiling over time by continuously reviewing prior results through the lens of newly emerging therapeutic evidence, helping ensure that patients and their physicians can benefit from ongoing advances in precision oncology."

In this large real‑world analysis, Caris evaluated 87 biomarker‑directed FDA approvals between 2018 and 2025 using a structured clinical impact framework. Approximately one-third of these approvals met criteria for inclusion in the Caris Lookback Program based on their potential clinical value and actionability. From a database of more than 483,000 molecular profiles, the program identified 13,293 patients potentially eligible for newly approved targeted therapies across 10 tumor types and multiple tumor‑agnostic indications.

The program's impact spanned a broad range of solid tumors, including non‑small cell lung, breast, colorectal and pancreatic cancers, with non‑small cell lung cancer accounting for approximately 40% of identified opportunities. The study also underscored the importance of multi‑modal profiling, as biomarker detection required diverse methodologies, including Whole Exome Sequencing (WES), Whole Transcriptome Sequencing (WTS), Immunohistochemistry (IHC) and combinations of these approaches.

Beyond molecular identification, the study also demonstrated the effectiveness of proactive clinical engagement. By integrating comprehensive molecular profiling with continuous evidence surveillance and targeted physician engagement, the Caris Lookback Program demonstrates how a single comprehensive test can deliver dynamic, longitudinal clinical utility, helping identify patients who may benefit from newly approved therapies without repeat biopsies or additional testing.

MI Cancer Seek® is the first and only simultaneous Whole Exome Sequencing (WES) and Whole Transcriptome Sequencing (WTS)-based assay with FDA-approved CDx indications for molecular profiling of solid tumors. MI Cancer Seek is available for adult and pediatric patients (ages 1+).

About Caris Life Sciences

Caris Life Sciences® (Caris) is a leading, patient-centric, next-generation AI TechBio company and precision medicine pioneer actively developing and commercializing innovative solutions to transform healthcare. Through comprehensive molecular profiling (Whole Genome, Whole Exome and Whole Transcriptome Sequencing), advanced AI and machine learning, 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 for developing the latest generation of advanced precision medicine diagnostic solutions for early detection, diagnosis, monitoring, therapy selection and drug development.  

Caris was founded with a vision to realize the potential of precision medicine to improve the human condition. 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.  

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the federal securities laws. All statements other than statements of historical facts contained in this press release are forward-looking statements, including statements regarding our business, solutions, plans, objectives, goals, industry trends, financial outlook and guidance. In some cases forward-looking statements can be identified by words such as "may," "will," "should," "would," "expect," "plan," "anticipate," "could," "intend," "target," "project,"  "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 medicine industry; our future financial performance, results of operations or other operational results or metrics; development, analytical and clinical validation, timing and performance of future solutions by us and our competitors; commercial market acceptance for our solutions, including acceptance of preventive as well as diagnostic testing paradigms, and our ability to meet resulting demand; the rapidly evolving competitive environment in which we operate; third-party payer reimbursement and coverage decisions related to our solutions; risks related to data management, storage, and processing capabilities and our ability to integrate and deploy artificial intelligence and advanced data analytics technologies; our ability to protect and enhance our intellectual property; regulatory requirements, decisions or approvals (including the timing and conditions thereof) related to our solutions; reliance on third-party suppliers; risks related to data security, patient privacy, and compliance with healthcare data protection regulations as well as potential cybersecurity threats to our data platforms; our compliance with laws and regulations; the outcome of government investigations and litigation; risks related to our indebtedness; 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 our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 3, 2026, 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

View original content to download multimedia:https://www.prnewswire.com/news-releases/caris-life-sciences-publishes-study-on-the-caris-lookback-program-demonstrating-the-ongoing-clinical-value-of-comprehensive-testing-with-caris-mi-cancer-seek-302773279.html

SOURCE Caris Life Sciences