Company Announcements

Inaugural story spotlights a woman whose presumed stage 4 metastatic breast cancer diagnosis was corrected by Caris GPSai, an AI-powered tissue-of-origin model, revealing a highly treatable lymphoma

IRVING, Texas , May 26, 2026 /PRNewswire/ -- Caris Life Sciences®, Inc. (NASDAQ: CAI), a leading, patient-centric, next-generation AI TechBio company and precision medicine pioneer, today launched "Behind the Diagnosis," a new campaign that spotlights patients whose care has been targeted and personalized by Caris' comprehensive molecular profiling and AI-powered precision medicine. The inaugural story features Erika Rios, who was diagnosed prior to Caris testing, with stage 4 metastatic triple-negative breast cancer. Caris GPSai®, the company's clinically validated tissue-of-origin AI model, available when ordering Caris MI Cancer Seek®, subsequently identified the true source of her disease as Hodgkin lymphoma, one of the most treatable cancers.

Erika presented in a visceral crisis and started chemotherapy based on an initial diagnosis of triple-negative breast cancer. Her treating oncologist, Vitor H. Pastorini Filho, MD, a board-certified hematologist and medical oncologist, questioned whether the clinical picture fit and ordered comprehensive molecular profiling with Caris GPSai to confirm the diagnosis. The AI model's analysis pointed to a different diagnosis, Hodgkin lymphoma, a hematologic cancer with a five-year relative survival rate of roughly 89% according to the American Cancer Society and a markedly different treatment pathway than metastatic breast cancer.

The GPSai algorithm can be ordered with Caris MI Cancer Seek at no additional cost. Caris received FDA approval in November 2024 for Caris MI Cancer Seek. This tissue-based assay is the first and only simultaneous Whole Exome Sequencing and Whole Transcriptome Sequencing-based assay with FDA-approved companion diagnostic (CDx) indications for molecular profiling of solid tumors.  

A recent peer-reviewed study published in JAMA Network Open showed that integrating Caris GPSai into routine molecular profiling identified 123 misdiagnoses across 3,958 cases submitted as presumed primary lung squamous cell carcinoma (SCC), a misdiagnosis rate of 3.1%. The true tumor origin spanned multiple lineages, including cutaneous SCC, urothelial carcinoma, and head and neck cancer. Following the diagnosis change, 71.5% of these patients experienced changes in eligibility for guideline-preferred first-line systemic therapy. Erika's case illustrates the same diagnostic dynamic in a different tumor type.

"Pathology is one of the most consequential decision points in oncology, because the diagnosis dictates therapy," said Matthew Oberley, MD, PhD, SVP, Chief Clinical Officer and Pathologist-in-Chief at Caris Life Sciences. "Erika's case illustrates what an AI-augmented, physician-in-the-loop approach can do when the clinical picture and the initial diagnosis do not align. By integrating tissue-of-origin prediction directly into routine molecular profiling, we give clinicians a powerful second look without requiring additional specimen or delay."

The clinical stakes of an accurate molecular diagnosis extend across the cancer care continuum. A correction in tumor lineage can open eligibility for targeted therapies that the original diagnosis would have ruled out, qualify a patient for a clinical trial previously closed to them, or remove a treatment recommendation that is unlikely to succeed against the actual disease. For patients facing a stage 4 label and a poor prognosis, an accurate redefinition of the disease can reshape the entire trajectory of care. Pairing comprehensive molecular profiling with AI brings that diagnostic clarity earlier in the patient journey, surfacing discrepancies in the routine workflow before treatment decisions are locked in.

Erika was successfully treated for her corrected diagnosis of Hodgkin lymphoma. In her story, Erika reflects on the diagnostic correction: "I cried like I had never cried in my life. I cried from happiness. I am living proof that Caris saves lives, and what it did for me, it can do for other patients."

"Behind the Diagnosis" will feature additional patient stories throughout the coming year, each illustrating a real-world clinical outcome made possible by truly comprehensive genomic profiling and AI. Watch Erika's story and learn more about the campaign on the Caris website.

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 Private Securities Litigation Reform Act of 1995 and other 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 on or about 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.

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

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