Caris Life Sciences Completes Interim Readout of Achieve 1 Study

Demonstrates Superior Sensitivity and Specificity of Caris Detect

Results demonstrate the superiority of Whole Genome Sequencing compared 

to methylation-based approaches

IRVING, Texas, Feb. 26, 2026 /PRNewswire/ -- Caris Life Sciences® (NASDAQ:CAI), a leading, patient-centric, next-generation AI TechBio company and precision medicine pioneer, today announced an interim readout of Achieve 1, the Company's study supporting the upcoming launch of Caris Detect™, its multi-cancer early detection (MCED) test. This interim readout of Achieve 1 represents a major milestone in Caris' goal to detect cancer earlier, when it is most treatable, through Whole Genome Sequencing, advanced AI and molecular insights.

Caris Detect leverages Caris' industry-leading molecular profiling data, which has surpassed one million cases processed and produced more than 50 billion molecular markers. This deep molecular foundation enables Caris' AI models to identify subtle biological signals associated with early-stage cancers with unprecedented resolution. 

Achieve 1 is evaluating Caris Detect across a broad population of patients, assessing its ability to detect multiple cancer types at early stages using a blood draw. For the undiagnosed cohort, which consisted of 1,505 samples, we utilized blood draws from subjects who had screening or symptomatic screening, a population reflecting a higher likelihood of cancer than the general population. We followed 22.5% of the subjects for approximately one year following their blood draw. Of these, 121 subjects had no symptoms of cancer, no significant risk factors of cancer and were not subsequently diagnosed with cancer, representing a healthy population.

The first phase of Achieve 1 utilized a cross-validation approach, with approximately 865 samples held out for a blinded validation that is in process. Caris expects to report those results later in the first quarter of 2026.

Study highlights and key performance data from the interim readout include:

• Sensitivity:
• 56.8% for Stage I (n=266)
• 70.1% for Stage II (n=137)
• 77.1% for Stage III (n=105)
• 99.1% for Stage IV (n=109)

• Sensitivity in Stage I and II Cancers (61.3% sensitivity)

• Specificity: 99.1% in the Asymptomatic Screening Population (n=121) and 95.3% in the Undiagnosed Population (n=1,505).
• Sample Size: 2,122, across 1,505 undiagnosed and 617 cancers from stages I through IV.
• 1,505 undiagnosed subjects from a screening and symptomatic screening population (the "Undiagnosed Population").
• 121 of these subjects with follow-up data had no symptoms of cancer, no significant risk factors of cancer and were not subsequently diagnosed with cancer within one year following blood draw (the "Asymptomatic Screening Population").
• In the ~600 undiagnosed subjects with one year of follow-up, roughly 7% of patients were subsequently diagnosed with cancer, indicating our enrollment criteria enriched for high-risk subjects.

"Our hypothesis has been that cancer is a disease driven by molecular aberrations that can manifest itself in many different forms. For example, driver mutations, changes in epigenomics, changes in transcriptomics and changes in aneuploidy," said David Spetzler, MS, PhD, MBA, President of Caris Life Sciences. "Most other attempts to derive insights into blood-based early detection modalities have relied upon epigenomics. Caris approached this from a broader biological perspective to encompass as many genomic alterations as can be attained from extreme ultra-deep Whole Genome Sequencing. This additional data has allowed us to achieve greater performance metrics than others and shows that methodologies focused on limited biological information are not sufficient to encompass the diversity of molecular aberrations driving cancer, especially in early-stage disease. Development of the next version of Caris Detect is currently underway with the aim of improving the already best-in-class performance with the incorporation of Whole Transcriptome Sequencing."

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: technical, operational and implementation requirements the failure of which affect the timing of or prevent commercialization of Caris Detect; future results regarding the blinded hold-out portion of the Achieve 1 samples as well as samples from Achieve 2; future performance and clinical utility of Caris Detect, including its AI models, when applied across larger real-world screening populations; 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. 

Caris Life Sciences Media:

Corporate Communications

[email protected]

214.294.5606

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SOURCE Caris Life Sciences