Caris Launches Proprietary AI Insights Signature Which Deepens Understanding of Response to Breast Cancer Patients' Oral Chemotherapy Drug

Rhea-AI Summary

Caris (NASDAQ: CAI) added a proprietary AI-driven breast cancer signature for capecitabine to its Caris Molecular Tumor Board Report, available with MI Cancer Seek. The signature uses more than 2,000 expression and copy-number features from WES and WTS to predict response in HER2-negative first-line breast cancer.

Caris noted MI Cancer Seek holds FDA approval (Nov 2024) as a WES/WTS-based tissue assay with companion diagnostic indications.

Positive

• FDA approval for MI Cancer Seek (Nov 2024)
• New capecitabine breast cancer signature added to Caris AI Insights
• Signature uses 2,000+ expression and copy-number features from WES and WTS
• Integrated into the Caris Molecular Tumor Board Report available with MI Cancer Seek

Negative

• None.

Key Figures

Genomic features used: more than 2,000 features

1 metrics

Genomic features used more than 2,000 features Expression and copy number features in WES/WTS profile for capecitabine response

Market Reality Check

Price: $18.20 Vol: Volume 3,273,457 vs 20-da...

normal vol

$18.20 Last Close

Volume Volume 3,273,457 vs 20-day average 2,399,024 (relative volume 1.36x) shows elevated trading interest. normal

Technical Shares at $17.64 are well below the $32.64 200-day MA and sitting near the $17.63 52-week low, versus a $56.215 52-week high.

Peers on Argus

While CAI is down 9.68%, key biotech peers like MDGL, MRNA and ROIV are up 3.2%,...

While CAI is down 9.68%, key biotech peers like MDGL, MRNA and ROIV are up 3.2%, 3.28% and 2.06% respectively, with HALO and VRNA roughly flat, pointing to a stock-specific move rather than a sector-wide decline.

Common Catalyst One peer, MDGL, reported conference participation, but there is no broad AI or diagnostics news theme across peers today.

Previous AI Reports

2 past events · Latest: Aug 06 (Positive)

Same Type Pattern 2 events

Date	Event	Sentiment	Move	Catalyst
Aug 06	AI survival study	Positive	-4.5%	AI image model linked to nearly doubled survival in breast cancer patients.
Aug 05	AI tissue origin study	Positive	+2.8%	AI platform showed best-in-class tissue-of-origin accuracy across large datasets.

Pattern Detected

AI-related announcements have produced mixed single-day reactions, with one positive and one negative move and an average change of -0.85%, suggesting no consistent upside pattern to AI news.

Recent Company History

Recent AI-tagged news for CAI focused on clinical validation of its AI platforms. In Aug 2025, a breast cancer survival study using an AI image model showed strong hazard ratio benefits, yet the stock fell 4.46%. A day earlier, publication of best-in-class tissue-of-origin accuracy (trained on over 200,000 cases) led to a 2.75% gain. Today’s AI breast cancer capecitabine signature extends this theme of AI-driven precision oncology but meets a much steeper selloff.

Historical Comparison

-0.8% avg move · In the past, CAI’s AI-tagged publications averaged a -0.85% one-day move. Today’s -9.68% reaction to...

AI

-0.8%

Average Historical Move AI

In the past, CAI’s AI-tagged publications averaged a -0.85% one-day move. Today’s -9.68% reaction to another AI breast cancer signature update is materially more negative than prior AI news responses.

AI efforts have progressed from image-based survival prediction and tissue-of-origin classification toward signatures that predict drug response (capecitabine) for specific breast cancer subgroups.

Market Pulse Summary

This announcement adds an AI-driven capecitabine response signature for HER2‑negative breast cancer ...

Analysis

This announcement adds an AI-driven capecitabine response signature for HER2‑negative breast cancer to the Caris Molecular Tumor Board Report, deepening the MI Cancer Seek ecosystem, which received FDA approval in November 2024. It reinforces Caris’ focus on Whole Exome and Whole Transcriptome sequencing and large-scale clinico-genomic data. Investors may track future updates on clinical validation, utilization of the new signature, upcoming earnings on February 26, 2026, and how AI capabilities integrate across oncology indications.

Key Terms

capecitabine, her2-negative, companion diagnostic (cdx), molecular profiling, +2 more

6 terms

capecitabine medical

"Caris recently added the breast cancer signature for capecitabine to the Caris AI Insights section"

An oral chemotherapy prodrug that converts in the body into an active cancer-fighting agent similar to 5-fluorouracil; think of it as a timed-release package that becomes active after swallowing. It matters to investors because its use, safety profile, patent status and competition from generics or alternative treatments directly affect sales, clinical-program value and regulatory risk for companies involved in oncology medicines.

her2-negative medical

"for first-line chemotherapy in HER2-negative breast cancer patients"

HER2-negative describes a cancer that does not have an excess of the HER2 protein on tumor cells; think of it as a door that lacks a specific lock that certain drugs are designed to fit. It matters to investors because it determines which therapies can work, how large the treatable patient group is, and the commercial and clinical prospects for drugs and trials targeting that subtype.

companion diagnostic (cdx) regulatory

"WTS)-based assay with FDA-approved companion diagnostic (CDx) indications for molecular profiling"

A companion diagnostic (CDx) is a medical test designed to identify which patients are likely to benefit from, or be harmed by, a specific drug or therapy—think of it as a key that shows which locks a particular medicine can open. For investors, a CDx matters because it shapes how many patients can use the drug, affects regulatory approval and reimbursement odds, and reduces commercial and clinical risk by targeting treatment to the right people.

molecular profiling medical

"companion diagnostic (CDx) indications for molecular profiling of solid tumors"

Molecular profiling is a laboratory analysis that reads a patient’s disease at the level of genes, proteins or other molecules to reveal its specific characteristics—think of it as reading the instruction manual for a tumor or condition. For investors, it matters because the results guide which targeted treatments, diagnostics or tests will be used, shaping clinical demand, regulatory approval paths and potential revenue for companies developing precision medicines and companion tests.

clinico-genomic medical

"multimodal clinico-genomic data and computing capability needed to analyze"

Clinico-genomic describes the combination of clinical patient information (symptoms, treatment outcomes, medical history) with genomic data (DNA changes and tumor genetics) to gain a fuller picture of disease and treatment response. For investors, this integrated approach can reveal which drugs are likely to work, identify new drug targets, and de-risk development programs — like fitting medical and genetic puzzle pieces together to predict which therapies will succeed in the market.

multi-cancer early detection (mced) medical

"a forthcoming multi-cancer early detection (MCED) blood assay"

A multi-cancer early detection (MCED) test is a single medical test, often a blood test, designed to screen for signs of many different cancers at once rather than targeting one type. Investors care because successful MCEDs could reshape healthcare by catching disease earlier, expanding screening markets, cutting long-term treatment costs, and creating large commercial and regulatory opportunities similar to how a single smartphone can replace many separate devices.

AI-generated analysis. Not financial advice.

IRVING, Texas, Feb. 24, 2026 /PRNewswire/ -- Caris Life Sciences^® (NASDAQ: CAI), a leading, patient-centric, next-generation AI TechBio company and precision medicine pioneer, today announced a new breast cancer signature included in the Caris Molecular Tumor Board Report. The Caris Molecular Tumor Board Report is an innovative research-use-only (RUO) tumor profiling report that provides an additional tumor biology resource and is available upon request when ordering MI Cancer Seek^®.

The Caris AI Insights section of the Caris Molecular Tumor Board Report includes signatures powered by artificial intelligence, including proprietary Caris signatures. These signatures leverage Caris' clinico-genomic data in predicting therapy response, identifying tissue of origin, assessing metastasis risk and guiding personalized treatment strategies for each patient.

Caris recently added the breast cancer signature for capecitabine to the Caris AI Insights section of the Caris Molecular Tumor Board Report. The signature utilizes more than 2,000 expression and copy number features from a patient's Whole Exome and Whole Transcriptome profile to predict response to capecitabine for first-line chemotherapy in HER2-negative breast cancer patients. Capecitabine is an oral chemotherapy drug used to treat breast cancer, among other cancers.

"Molecular profiling is a vital step in gaining a comprehensive understanding of a patient's cancer," said Caris President David Spetzler, MS, PhD, MBA. "Caris AI Insights help researchers and clinicians provide a valuable molecular blueprint of a patient's tumor biology and is another way Caris' testing goes above and beyond for patients, clinicians and researchers." 

The Caris Molecular Tumor Board Report is available upon request when ordering MI Cancer Seek.

Caris received FDA approval in November 2024 for MI Cancer Seek, a tissue-based assay that is the first and only simultaneous Whole Exome Sequencing (WES) and Whole Transcriptome Sequencing (WTS)-based assay with FDA-approved companion diagnostic (CDx) indications for molecular profiling of solid tumors.

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," "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 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 Quarterly Report on Form 10-Q filed on or about November 5, 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 

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SOURCE Caris Life Sciences

FAQ

What does Caris (CAI) announce about the new capecitabine breast cancer signature?

The company added an AI-driven signature to predict capecitabine response in HER2-negative breast cancer. According to Caris, it uses more than 2,000 expression and copy-number features from Whole Exome and Whole Transcriptome profiles to inform first-line therapy response predictions.

How will the new Caris signature for capecitabine be accessed by clinicians ordering MI Cancer Seek (CAI)?

The signature is included in the Caris Molecular Tumor Board Report provided upon request with MI Cancer Seek orders. According to Caris, clinicians who order MI Cancer Seek can request the report to receive the Caris AI Insights signatures.

Does the new signature change MI Cancer Seek's regulatory status for Caris (CAI)?

No regulatory change was announced; MI Cancer Seek already has FDA approval from November 2024. According to Caris, MI Cancer Seek remains the FDA-approved WES/WTS-based tissue assay with companion diagnostic indications.

What data types power the Caris AI Insights capecitabine signature for CAI patients?

The signature is powered by Whole Exome Sequencing and Whole Transcriptome Sequencing features. According to Caris, it leverages over 2,000 expression and copy-number features drawn from patients' WES and WTS profiles.

How might the capecitabine signature affect treatment decisions for HER2-negative breast cancer patients (CAI)?

The signature is designed to predict likely response to capecitabine for first-line therapy. According to Caris, the AI Insights offer a molecular blueprint intended to help researchers and clinicians guide personalized treatment strategies.