Caris Life Sciences Finalizes Achieve 1 Study Results Reinforcing the Superior Sensitivity and Specificity of Caris Detect

Caris Life Sciences (NASDAQ: CAI) finalized Achieve 1 results for Caris Detect, a multi-cancer early detection test using Whole Genome Sequencing.

Rhea-AI Summary

Caris Life Sciences (NASDAQ: CAI) finalized Achieve 1 results for Caris Detect, a multi-cancer early detection test using Whole Genome Sequencing. The study enrolled 3,014 evaluable subjects and reported overall Stage I–II sensitivity ~60.3% and high specificities (asymptomatic 99.2%, benign/high-risk 96.0%). Stage-specific sensitivity ranged from 56.8% (Stage I) to 98.6% (Stage IV).

The company emphasized WGS superiority over methylation-only approaches and plans to add additional pillars, including Whole Transcriptome Sequencing, to improve performance.

Positive

• 3,014 subjects enrolled and evaluable
• Stage I–II sensitivity approximately 60.3%
• Asymptomatic specificity 99.2%
• Benign/high-risk specificity 96.0%
• Stage IV sensitivity 98.6%

Negative

• Stage I sensitivity 56.8%, indicating limited early-stage detection
• Blinded set exclusions: 36 without staging, 34 on treatment, 24 failed sample quality

Argus Apr 1 session

+6.99% close to close Open Argus

Details

News Market Reaction – CAI

In the Apr 1 session, CAI gained 6.99%, reflecting a notable positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

The stock moved +7.0% in the session following this news. A strong positive reaction aligns with the...

Analysis

The stock moved +7.0% in the session following this news. A strong positive reaction aligns with the clinically meaningful Achieve 1 data, especially high specificity and robust late-stage sensitivity. Earlier AI and diagnostics announcements sometimes saw weak or negative moves despite positive fundamentals. This move followed a series of R&D updates and insider equity grants disclosed in March 10 Form 4 filings, suggesting investors responded more decisively once full Caris Detect performance metrics were disclosed.

Key Figures

Study subjects: 3,014 subjects Stage I sensitivity: 56.8% (n=343) Stage II sensitivity: 67.7% (n=191) +5 more

Study subjects

3,014 subjects

Achieve 1 Study enrolled and evaluable cohort

Stage I sensitivity

56.8% (n=343)

Total Achieve 1 Study results for Stage I cancers

Stage II sensitivity

67.7% (n=191)

Total Achieve 1 Study results for Stage II cancers

Stage III sensitivity

79.0% (n=143)

Total Achieve 1 Study results for Stage III cancers

Stage IV sensitivity

98.6% (n=145)

Total Achieve 1 Study results for Stage IV cancers

Asymptomatic specificity

99.2% (n=141)

Total Achieve 1 Study results for asymptomatic population

Benign/high-risk specificity

96.0% (n=2051)

Total Achieve 1 Study results in benign/high-risk subjects

Stage I & II sensitivity

60.3% (n=131)

Combined early-stage sensitivity for Achieve 1 Study

Historical Context

5 past events · Latest: Mar 26

5 events

1. Mar 26

   AI risk signatures

   24h Move

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   New AI signatures predicting brain metastases risk in breast and NSCLC.

2. Mar 25

   Conference presentations

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   Six oncology studies accepted for presentation at AACR Annual Meeting 2026.

3. Mar 24

   Testing awareness push

   24h Move

   -0.1%

   Highlighting DPYD testing integration in Caris Assure during awareness month.

4. Mar 20

   GPSai study results

   24h Move

   -2.1%

   JAMA study showing GPSai reclassifies diagnoses and changes first-line therapy.

5. Mar 16

   New AI resistance tool

   24h Move

   +3.5%

   Launch of AI insight to predict early platinum resistance in ovarian cancer.

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

Key Terms

whole genome sequencing, methylation-based approaches, multi-cancer early detection (mced), peripheral blood sampling, +1 more

5 terms

whole genome sequencing medical

"Results demonstrate the superiority of Whole Genome Sequencing compared to methylation-based"

Whole genome sequencing is a laboratory method that reads an individual’s complete DNA instruction book, capturing all genetic letters rather than just selected parts. For investors, it matters because it can reveal new ways to diagnose, prevent or treat disease and to develop tests or drugs — like upgrading from a map of a few streets to a full city blueprint — which can create commercial opportunities, influence regulatory pathways and change healthcare costs and demand.

methylation-based approaches medical

"superiority of Whole Genome Sequencing compared to methylation-based approaches"

Techniques that read patterns of chemical tags placed on DNA—called methylation—that act like sticky notes turning genes up or down. Investors care because these patterns can serve as reliable biomarkers for detecting disease, tracking treatment response, or screening populations, which can create diagnostic tests, monitoring tools, and recurring clinical services with clear commercial and regulatory pathways.

multi-cancer early detection (mced) medical

"Caris Detect™, its multi-cancer early detection (MCED) test."

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.

peripheral blood sampling medical

"identifying multiple cancer types at early stages through peripheral blood sampling."

Peripheral blood sampling is the routine collection of blood from a vein, usually in the arm, to measure things like cell counts, drug levels, or biomarkers; think of it like taking a quick oil check to see how a system is running. Investors care because these samples are central to clinical trial monitoring, diagnostic testing and regulatory submissions—methods that affect a program’s cost, patient enrollment, safety profile and timeline to approval.

molecular profiling medical

"Caris' industry-leading molecular profiling data, which has processed more than 1 million cases"

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

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Results demonstrate the superiority of Whole Genome Sequencing compared to methylation-based approaches

IRVING, Texas, March 31, 2026 /PRNewswire/ -- Caris Life Sciences^® (NASDAQ: CAI), a leading, patient-centric, next-generation AI TechBio company and precision medicine pioneer, today announced the finalized Achieve 1 Study results. These results represent a major milestone in Caris' goal to detect cancer earlier, through the future launch of Caris Detect™, its multi-cancer early detection (MCED) test. 

Caris Detect leverages Caris' industry-leading molecular profiling data, which has processed more than 1 million cases and generated more than 50 billion molecular markers. This deep molecular foundation enables Caris' AI models to identify, with unprecedented resolution, difficult-to-detect biological signals associated with early-stage cancers. 

The Achieve 1 Study systematically assessed Caris Detect's diagnostic accuracy across a heterogeneous patient cohort, quantifying its efficacy in identifying multiple cancer types at early stages through peripheral blood sampling. A total of 3,014 subjects were enrolled and evaluable based on high-risk screening, symptomatic presentation, or identification of a mass on imaging, representing a population with elevated cancer prevalence relative to baseline.

Achieve 1 results in totality included:

	Interim	Blinded	Total
Stage I Sensitivity	56.8% (n=266)	58.4% (n=77)	56.8% (n=343)
Stage II Sensitivity	70.1% (n=137)	63.0% (n=54)	67.7% (n=191)
Stage III Sensitivity	77.1% (n=105)	84.2% (n=38)	79.0% (n=143)
Stage IV Sensitivity	99.1% (n=109)	97.1% (n=36)	98.6% (n=145)
Asymptomatic Specificity	99.1% (n=121)	100% (n=20)	99.2% (n=141)
Benign/High Risk Specificity	95.3% (n=1505)	98.1% (n=546)	96.0% (n=2051)

• Sensitivity in Stage I and II Cancers 60.3% (n=131)

	Stage I & II Sensitivity
Cancer	Interim	Blinded	Total
Breast	53.0% (n=253)	59.1% (n=44)	53.7% (n=297)
Prostate	78.9% (n=38)	65.0% (n=20)	74.1% (n=58)
Lung	86.7% (n=15)	60.0% (n=15)	73.4% (n=30)
Uterus	73.7% (n=19)	46.1% (n=13)	60.6% (n=32)
Bowel	62.2% (n=45)	60.0% (n=10)	61.8% (n=55)
Head and Neck	100.0% (n=7)	66.7% (n=9)	81.3% (n=16)
Skin	50.0% (n=2)	75.0% (n=4)	66.7% (n=6)
Pancreas	71.4% (n=7)	66.7% (n=3)	70.0% (n=10)
Other	88.2% (n=17)	57.1% (n=13)	69.7% (n=30)

Of note, in the blinded validation set, 36 cancer patients had no staging information, 34 were on treatment or blood was collected after intent-to-treat surgery, and 24 failed to produce results meeting minimum sample quality metrics. Each of these patient groups were excluded from the results.

"Finalizing the Achieve 1 results is a pivotal milestone for Caris Detect, because it moves our performance assessment from an interim view to a complete, reported-out data set," said David Spetzler, MS, PhD, MBA, President of Caris Life Sciences. "This data was generated analyzing only one of nine pillars. With this study, we have validated that our Whole Genome Sequencing approach detects the diverse molecular changes that drive cancer and quantifies performance with greater confidence across stages and patient populations. This data reinforces our view that relying on a narrow slice of biology is not sufficient for early detection. We intend to add additional pillars, including Whole Transcriptome Sequencing, which we believe will strengthen and improve the overall performance of the test."

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 sensitivity did Caris Detect show for Stage I cancer in the Achieve 1 study (CAI)?

Caris Detect showed a Stage I sensitivity of 56.8%, measured across 343 total Stage I cases. According to the company, this reflects performance from their Whole Genome Sequencing approach in the completed Achieve 1 data set.

How specific was Caris Detect among asymptomatic subjects in Achieve 1 (CAI)?

Asymptomatic specificity was reported at 99.2% in the total cohort, indicating low false-positive rates. According to the company, this specificity was calculated from 141 asymptomatic samples in the study.

How many subjects were enrolled and evaluable in Caris Life Sciences' Achieve 1 study (CAI)?

Achieve 1 enrolled and produced evaluable data for 3,014 subjects across high-risk, symptomatic, or imaging-identified populations. According to the company, this cohort has elevated cancer prevalence versus baseline screening populations.

What overall sensitivity did Caris Detect achieve for Stage I and II cancers combined (CAI)?

Combined Stage I and II sensitivity was approximately 60.3%, reflecting the test's early-stage detection capability. According to the company, this metric summarizes performance across cancers in the Achieve 1 data set.

What changes does Caris Life Sciences plan to improve Caris Detect after Achieve 1 (CAI)?

Caris plans to add additional biological pillars such as Whole Transcriptome Sequencing to strengthen performance. According to the company, Achieve 1 analyzed one of nine pillars and further pillars aim to improve sensitivity and resolution.