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Caris Life Sciences Highlights the Importance of DPYD Testing in Colorectal Cancer During Colorectal Cancer Awareness Month

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Caris Life Sciences (NASDAQ: CAI) emphasized the importance of DPYD testing for colorectal cancer patients during Colorectal Cancer Awareness Month on March 24, 2026. The company noted the FDA updated safety labeling for capecitabine and 5-FU and incorporated DPYD reporting into its blood-based Caris Assure Whole Exome and Whole Transcriptome Sequencing assay.

This integration enables clinicians to detect inherited DPYD variants from a single blood draw, aiming to inform fluoropyrimidine therapy decisions and reduce risk of severe toxicity before treatment begins.

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Positive

  • FDA safety labeling updated for capecitabine and 5-FU
  • Caris integrated DPYD reporting into Caris Assure assay
  • Blood-based WES/WTS enables inherited and tumor biomarker assessment

Negative

  • DPYD screening remains inconsistent across care settings

Caris reinforces the value of Whole Exome Sequencing and Whole Transcriptome Sequencing testing for cancer patients

IRVING, Texas, March 24, 2026 /PRNewswire/ -- Caris Life Sciences® (NASDAQ: CAI), a leading patient-centric, next-generation AI TechBio company and precision medicine pioneer, is recognizing Colorectal Cancer Awareness Month by highlighting the critical role of DPYD testing in helping to inform treatment for patients with colorectal cancer.

Colorectal cancer remains one of the most commonly diagnosed cancers in the United States and is a leading cause of cancer-related death. Recent American Cancer Society data underscore the ongoing burden of the disease, including rising incidence in younger adults, reinforcing the need for earlier detection, more personalized care and greater awareness of testing that may influence treatment decisions.

For many patients with colorectal cancer, fluoropyrimidine-based therapies such as capecitabine and fluorouracil remain a cornerstone of treatment. However, certain inherited variants in the DPYD gene can reduce dihydropyrimidine dehydrogenase (DPD) enzyme activity, increasing the risk of severe, and in some cases life-threatening, toxicity from these common therapies. The FDA has updated safety labeling for capecitabine and 5-FU to increase awareness of DPD deficiency risks and advises testing patients for genetic variants of DPYD prior to treatment initiation unless immediate therapy is necessary.

Despite growing clinical awareness and guideline support for considering DPYD testing prior to treatment, screening remains inconsistent across care settings, leaving many patients and providers unaware of a risk that can have profound clinical consequences. Caris addresses this gap by incorporating DPYD reporting into Caris Assure®, its blood-based Whole Exome Sequencing and Whole Transcriptome Sequencing molecular profiling assay. This allows clinicians to assess not only tumor biomarkers, but also clinically relevant inherited variants from a single blood draw, streamlining care while expanding the actionable information available before treatment begins. By identifying inherited variants in the DPYD gene before therapy, physicians may be able to reduce the risk of serious toxicity associated with fluoropyrimidine-based chemotherapies.

"In precision oncology, treatment selection is not only about identifying what may work but also understanding factors that may affect how safely a patient can receive therapy," said Caris President David Spetzler, MS, PhD, MBA. "During Colorectal Cancer Awareness Month, it is important to recognize that DPYD testing can provide clinically meaningful information before treatment begins, helping clinicians make more informed decisions for patients who may be candidates for fluoropyrimidine-based therapy."

As the oncology community continues to advance more individualized care, Caris believes awareness of pharmacogenomic factors like DPYD status is an important part of the broader precision medicine conversation in colorectal cancer. Increasing education around biomarker-informed care may help support safer treatment planning and improve the patient's experience.

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 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 

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SOURCE Caris Life Sciences

FAQ

What did Caris announce about DPYD testing for colorectal cancer on March 24, 2026 (CAI)?

Caris highlighted the clinical importance of DPYD testing and its inclusion in Caris Assure. According to the company, Caris Assure now reports inherited DPYD variants from a single blood-based Whole Exome and Whole Transcriptome Sequencing assay.

How does Caris Assure report DPYD variants and why does this matter for CAI investors?

Caris Assure reports inherited DPYD variants via blood-based WES/WTS prior to treatment. According to the company, this allows clinicians to assess tumor and germline biomarkers from one draw, potentially informing safer fluoropyrimidine therapy decisions.

What did the FDA change about capecitabine and 5-FU labeling relevant to CAI news?

The FDA updated safety labeling to increase awareness of DPD deficiency risks before treatment. According to the company, the labeling advises testing for DPYD variants unless immediate therapy is required.

Will DPYD testing with Caris Assure reduce chemotherapy toxicity risk for colorectal cancer patients?

Identifying DPYD variants can help clinicians anticipate increased toxicity risk from fluoropyrimidines. According to the company, pre-treatment detection of DPYD variants may enable dose adjustments or alternative plans to reduce severe toxicity risk.

Why is DPYD screening inconsistent across care settings despite guideline support noted by CAI?

Screening remains uneven due to variable clinical adoption and awareness among providers. According to the company, broader education and integrated testing options like Caris Assure aim to improve consistent DPYD screening uptake.

How does Caris position DPYD testing within its broader precision medicine offerings (CAI)?

Caris frames DPYD testing as part of multimodal molecular profiling to inform therapy selection and safety. According to the company, combining WES and WTS with germline reporting supports more individualized treatment planning for colorectal cancer patients.
Caris Life Sciences, Inc.

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