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 |
99.1% (n=121) |
100% (n=20) |
99.2% (n=141) |
|
Benign/High Risk |
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
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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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