Caris Life Sciences Launches Behind the Diagnosis Campaign Spotlighting Patient Lives Transformed by Caris' Comprehensive Genomic Testing

Caris Life Sciences (NASDAQ: CAI) launched the “Behind the Diagnosis” campaign highlighting real patients whose treatment was informed by Caris’ comprehensive genomic profiling and AI.

Rhea-AI Summary

Caris Life Sciences (NASDAQ: CAI) launched the “Behind the Diagnosis” campaign highlighting real patients whose treatment was informed by Caris’ comprehensive genomic profiling and AI.

The first story features Caris GPSai correcting a presumed metastatic breast cancer to highly treatable Hodgkin lymphoma, and references FDA-approved MI Cancer Seek and clinical data on GPSai’s impact on misdiagnosis and therapy eligibility.

Positive

• Caris GPSai corrected a presumed metastatic breast cancer to Hodgkin lymphoma, enabling successful treatment
• Caris MI Cancer Seek received FDA approval in November 2024 with companion diagnostic indications
• MI Cancer Seek offers first FDA-approved assay combining Whole Exome and Whole Transcriptome Sequencing for solid tumors
• Peer-reviewed study found GPSai identified 123 misdiagnoses among 3,958 presumed lung SCC cases (3.1%)
• After GPSai-driven diagnosis changes, 71.5% of patients had altered eligibility for guideline-preferred first-line systemic therapy
• GPSai can be ordered with MI Cancer Seek at no additional cost, supporting broader clinical adoption

Negative

• None.

Argus May 26 session

-0.19% close to close Open Argus

Details

News Market Reaction – CAI

On May 26, the day this news came out, CAI closed 0.19% below the previous close.

Data tracked by StockTitan Argus for the May 26 session.

Key Figures

Five-year survival rate: 89% Cases analyzed: 3,958 cases Misdiagnoses identified: 123 cases +3 more

Five-year survival rate

89%

Hodgkin lymphoma five-year relative survival rate

Cases analyzed

3,958 cases

JAMA Network Open GPSai misdiagnosis study cohort size

Misdiagnoses identified

123 cases

Misdiagnoses found among presumed lung SCC cases

Misdiagnosis rate

3.1%

Share of 3,958 presumed lung SCC cases reclassified by GPSai

Therapy eligibility changes

71.5%

Patients whose guideline-preferred first-line eligibility changed after reclassification

FDA approval date

November 2024

FDA approval timing for Caris MI Cancer Seek assay

Historical Context

5 past events · Latest: May 15

5 events

1. May 15

   Clinical study update

   24h Move

   -4.6%

   Study showed MI Cancer Seek unlocks eligibility for new targeted therapies.

2. May 11

   Clinical study update

   24h Move

   -1.3%

   WES-based TMB measurement linked to better prediction of pembrolizumab benefit.

3. May 08

   Regulatory application

   24h Move

   -1.3%

   Applied for New York authorization for Caris Assure blood-based profiling.

4. May 07

   Earnings report

   24h Move

   -18.6%

   Q1 2026 results showed strong revenue growth and improved cash flow metrics.

5. May 05

   AI product launch

   24h Move

   +1.4%

   Launch of MI Clarity AI test for distant recurrence risk in breast cancer.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

tissue-of-origin, Hodgkin lymphoma, hematologic cancer, companion diagnostic (CDx), +2 more

6 terms

tissue-of-origin medical

"Caris GPSai, an AI-powered tissue-of-origin model, revealing a highly treatable..."

Tissue-of-origin is the medical identification of the specific body tissue where a disease, especially a tumor or a circulating biomarker, first began. For investors, knowing tissue-of-origin matters because it guides which tests, drugs, or treatments are appropriate and affects potential market size, regulatory path, and reimbursement—similar to reading a postcard’s return address to decide where to send resources and what solutions will work best.

Hodgkin lymphoma medical

"identified the true source of her disease as Hodgkin lymphoma, one of the most..."

Hodgkin lymphoma is a cancer of the lymphatic system, the body’s network that helps fight infection, where certain immune cells grow uncontrollably and form tumors. It matters to investors because diagnoses, new treatments, clinical trial results, or regulatory approvals can quickly change demand for drugs, shape a company’s revenue outlook, and alter healthcare costs—similar to how a surprise product breakthrough can shift a company’s market prospects.

hematologic cancer medical

"Hodgkin lymphoma, a hematologic cancer with a five-year relative survival rate..."

Hematologic cancer is cancer that starts in the blood, bone marrow, or lymphatic system—the body’s delivery and defense network—such as leukemia, lymphoma, and myeloma. It matters to investors because these diseases drive demand for specific diagnostics, therapies and long-term care, shape clinical trial pipelines and regulatory risk, and can significantly affect the revenue and valuation of companies developing treatments or diagnostic tools.

companion diagnostic (CDx) regulatory

"assay with FDA-approved companion diagnostic (CDx) indications for molecular..."

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

"ordered comprehensive molecular profiling with Caris GPSai to confirm the..."

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.

AI-augmented technical

"Erika's case illustrates what an AI-augmented, physician-in-the-loop approach can do..."

AI-augmented describes tools, products, or workflows where artificial intelligence is used together with human judgment to improve performance—like power steering that helps a driver handle a car more precisely and with less effort. For investors, AI augmentation can mean faster decision-making, lower operating costs, new product features and potentially higher growth, but it also brings execution, ethical and regulatory risks that can affect returns.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

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

View original content to download multimedia:https://www.prnewswire.com/news-releases/caris-life-sciences-launches-behind-the-diagnosis-campaign-spotlighting-patient-lives-transformed-by-caris-comprehensive-genomic-testing-302780812.html

SOURCE Caris Life Sciences

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What is Caris Life Sciences' "Behind the Diagnosis" campaign for NASDAQ: CAI?

The "Behind the Diagnosis" campaign shares real patient stories where Caris’ genomic profiling and AI influenced care. According to Caris, it highlights how comprehensive molecular testing and GPSai tissue-of-origin models can reshape diagnoses, treatment paths, and outcomes across different cancer types.

How did Caris GPSai change a patient's diagnosis in the new CAI campaign?

Caris GPSai reclassified a presumed stage 4 triple-negative breast cancer as Hodgkin lymphoma for patient Erika Rios. According to Caris, this AI-driven tissue-of-origin insight led to a different, highly treatable diagnosis and successful therapy, dramatically altering her prognosis and care journey.

What is Caris MI Cancer Seek and when did it receive FDA approval (NASDAQ: CAI)?

Caris MI Cancer Seek is a tissue-based molecular profiling assay combining whole exome and whole transcriptome sequencing. According to Caris, it received FDA approval in November 2024 and includes companion diagnostic indications for solid tumors, supporting more precise, genomically informed cancer treatment decisions.

What did the JAMA Network Open study show about Caris GPSai for CAI investors?

The JAMA Network Open study reported GPSai identified 123 misdiagnoses among 3,958 presumed lung squamous cell carcinoma cases. According to Caris, this 3.1% misdiagnosis rate led to diagnosis changes that altered eligibility for guideline-preferred first-line systemic therapy in 71.5% of affected patients.

How can clinicians access Caris GPSai with MI Cancer Seek for NASDAQ: CAI?

Clinicians can order the GPSai tissue-of-origin model together with Caris MI Cancer Seek at no additional cost. According to Caris, this integration brings AI-based origin prediction into routine molecular profiling without extra specimen needs or delays, acting as a second look on complex cases.

Why is accurate tissue-of-origin diagnosis important in Caris Life Sciences' approach (CAI)?

Accurate tissue-of-origin diagnosis guides the choice of systemic therapy, trials, and targeted treatments. According to Caris, correcting tumor lineage can unlock options otherwise missed, prevent unlikely-to-succeed regimens, and significantly reshape the care path, particularly for patients initially labeled with advanced-stage disease.