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

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.

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)

AsymptomaticSpecificity

99.1% (n=121)

100% (n=20)

99.2% (n=141)

Benign/High RiskSpecificity

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," saidDavid 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 SciencesCaris 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.

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SOURCE Caris Life Sciences