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Caris Life Sciences Publishes Study Showing AI Signature-positive Breast Cancer Patients Live Almost Twice as Long as AI-negative Patients When Treated with a Checkpoint Inhibitor

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Caris Life Sciences (NASDAQ: CAI) has published a groundbreaking study in Communications Medicine demonstrating the superior effectiveness of their AI-based image analysis model in predicting cancer biomarkers and patient survival. The study, analyzing data from over 35,000 patients, showed remarkable results in breast cancer patients treated with pembrolizumab, achieving a hazard ratio of 0.511 (p<0.001) compared to 0.882 (p>0.1) for traditional PD-L1 testing methods.

The AI model's analysis of H&E images demonstrated nearly doubled overall survival for AI signature-positive breast cancer patients treated with checkpoint inhibitors. In colorectal cancer, the AI successfully predicted mismatch repair deficiency and microsatellite instability comparable to traditional scoring methods.

Caris Life Sciences (NASDAQ: CAI) ha pubblicato uno studio innovativo su Communications Medicine che dimostra l'efficacia superiore del loro modello di analisi delle immagini basato su intelligenza artificiale nella previsione dei biomarcatori tumorali e della sopravvivenza dei pazienti. Lo studio, che ha analizzato i dati di oltre 35.000 pazienti, ha evidenziato risultati straordinari nei pazienti con tumore al seno trattati con pembrolizumab, raggiungendo un hazard ratio di 0,511 (p<0,001) rispetto a 0,882 (p>0,1) per i metodi tradizionali di test PD-L1.

L'analisi del modello AI sulle immagini H&E ha mostrato un raddoppio quasi completo della sopravvivenza complessiva per i pazienti con tumore al seno positivi alla firma AI trattati con inibitori del checkpoint. Nel cancro colorettale, l'AI ha previsto con successo la carenza di riparazione degli errori di appaiamento e l'instabilità dei microsatelliti in modo comparabile ai metodi di valutazione tradizionali.

Caris Life Sciences (NASDAQ: CAI) ha publicado un estudio pionero en Communications Medicine que demuestra la efectividad superior de su modelo de análisis de imágenes basado en inteligencia artificial para predecir biomarcadores de cáncer y la supervivencia de los pacientes. El estudio, que analizó datos de más de 35,000 pacientes, mostró resultados notables en pacientes con cáncer de mama tratados con pembrolizumab, alcanzando una razón de riesgo de 0.511 (p<0.001) en comparación con 0.882 (p>0.1) para los métodos tradicionales de prueba PD-L1.

El análisis del modelo de IA sobre imágenes H&E demostró casi el doble de supervivencia general para pacientes con cáncer de mama positivos a la firma de IA tratados con inhibidores de puntos de control. En el cáncer colorrectal, la IA predijo con éxito la deficiencia de reparación por desajuste y la inestabilidad de microsatélites de manera comparable a los métodos tradicionales de puntuación.

Caris Life Sciences (NASDAQ: CAI)� Communications Medicine� 혁신적인 연구� 발표하여 � 바이오마커와 환자 생존� 예측� 있어 AI 기반 이미지 분석 모델� 우수� 효과� 입증했습니다. 35,000� 이상� 환자 데이터를 분석� � 연구� 펨브롤리주맙으로 치료받은 유방� 환자에서 기존 PD-L1 검� 방법 대� 0.511 (p<0.001)� 위험비를 달성하며 뛰어� 결과� 보였습니� (기존 방법은 0.882, p>0.1).

AI 모델� H&E 이미지� 분석� 결과, 체크포인� 억제제로 치료받은 AI 시그니처 양성 유방� 환자� 전체 생존율이 거의 � � 가까이 증가했습니다. 대장암에서� AI가 기존 평가 방법� 유사하게 불일� 복구 결함� 마이크로새틀라이� 불안정을 성공적으� 예측했습니다.

Caris Life Sciences (NASDAQ: CAI) a publié une étude révolutionnaire dans Communications Medicine démontrant l'efficacité supérieure de leur modèle d'analyse d'images basé sur l'intelligence artificielle pour prédire les biomarqueurs du cancer et la survie des patients. L'étude, analysant les données de plus de 35 000 patients, a montré des résultats remarquables chez les patientes atteintes de cancer du sein traitées par pembrolizumab, avec un rapport de risque de 0,511 (p<0,001) comparé à 0,882 (p>0,1) pour les méthodes traditionnelles de test PD-L1.

L'analyse du modèle IA des images H&E a démontré une survie globale presque doublée chez les patientes atteintes d'un cancer du sein positives à la signature IA traitées par inhibiteurs de points de contrôle. Dans le cancer colorectal, l'IA a prédit avec succès la déficience de réparation des mésappariements et l'instabilité des microsatellites, de manière comparable aux méthodes traditionnelles d'évaluation.

Caris Life Sciences (NASDAQ: CAI) hat eine bahnbrechende Studie in Communications Medicine veröffentlicht, die die überlegene Wirksamkeit ihres KI-basierten Bildanalysemodells bei der Vorhersage von Krebs-Biomarkern und dem Überleben von Patienten zeigt. Die Studie, die Daten von über 35.000 Patienten analysierte, zeigte bemerkenswerte Ergebnisse bei Brustkrebspatienten, die mit Pembrolizumab behandelt wurden, mit einem Hazard Ratio von 0,511 (p<0,001) im Vergleich zu 0,882 (p>0,1) bei herkömmlichen PD-L1-Testmethoden.

Die Analyse des KI-Modells von H&E-Bildern zeigte nahezu eine Verdopplung des Gesamtüberlebens bei KI-Signatur-positiven Brustkrebspatienten, die mit Checkpoint-Inhibitoren behandelt wurden. Beim kolorektalen Krebs sagte die KI erfolgreich die Mismatch-Reparaturdefizienz und Mikrosatelliteninstabilität ähnlich wie traditionelle Bewertungsmethoden vorher.

Positive
  • AI model demonstrates almost double survival rate for breast cancer patients compared to traditional testing methods
  • Successfully analyzed large-scale data from over 35,000 patients
  • AI technology shows equivalent accuracy to traditional scoring in colorectal cancer detection
  • Potential to improve efficiency and accuracy of cancer patient evaluation
Negative
  • Technology still requires further clinical validation and regulatory approvals
  • Implementation may face reimbursement challenges from third-party payers

Insights

Caris' AI model demonstrates superior prediction of immunotherapy response in cancer patients, potentially revolutionizing treatment selection and doubling survival rates.

This publication in Communications Medicine represents a significant advancement in precision oncology. Caris Life Sciences has developed an AI model that analyzes standard H&E stained tissue images to predict biomarker status with greater accuracy than conventional companion diagnostic methods. The most striking finding is in breast cancer patients treated with pembrolizumab (an immune checkpoint inhibitor), where the AI-positive signature correlated with nearly doubled overall survival compared to traditional PD-L1 testing methods.

The hazard ratio of 0.511 (p<0.001) for the AI model versus 0.882 (p>0.1) for traditional PD-L1 immunohistochemistry indicates substantially improved predictive power. This is particularly important because conventional PD-L1 testing has known limitations, especially near the critical 1% expression threshold that determines treatment eligibility. By more accurately identifying responsive patients, this AI approach could significantly expand the population benefiting from immunotherapy while sparing non-responders from unnecessary treatment.

The study's scale is impressive, analyzing over 35,000 patient samples from Caris' clinico-genomic database. Beyond breast cancer, the AI model also demonstrated equivalent accuracy to traditional methods in predicting mismatch repair deficiency and microsatellite instability in colorectal cancer - both critical biomarkers for immunotherapy response.

This research exemplifies how AI can enhance pathologist capabilities rather than replace them, potentially streamlining the diagnostic workflow while improving accuracy. If validated in prospective studies, this approach could transform immunotherapy patient selection paradigms and represents a significant competitive advantage for Caris in the precision oncology market.

Caris Life Sciences has achieved a potentially game-changing breakthrough in AI-driven cancer diagnostics with significant market implications. Their AI model demonstrates superior predictive power compared to current gold-standard diagnostic methods, particularly for immunotherapy response in breast cancer patients.

The most commercially significant finding is the hazard ratio of 0.511 for overall survival when using their AI model to predict immunotherapy response, compared to just 0.882 with traditional methods. This translates to patients identified by Caris' AI living almost twice as long when receiving pembrolizumab - a dramatic improvement in patient selection that could drive significant adoption.

This technology addresses critical limitations in the current $2+ billion cancer companion diagnostics market, particularly for PD-L1 testing which suffers from interpretation challenges and borderline cases. By analyzing standard H&E slides, Caris' approach also offers potential cost and workflow advantages over specialized immunohistochemistry tests.

For Caris, which recently went public in 2025, this publication in a prestigious Nature portfolio journal provides strong validation of their AI TechBio strategy. The study's massive scale (35,000+ patients) demonstrates Caris' data advantage and computational capabilities - key differentiators in the competitive precision medicine landscape.

While regulatory approval and clinical adoption will take time, this publication positions Caris to potentially capture significant market share in the rapidly growing precision oncology sector. The technology could become an essential component of immunotherapy patient selection, creating new revenue opportunities through both testing services and potential licensing to pharmaceutical partners developing checkpoint inhibitors.

Groundbreaking study in Nature Communications highlights AI's role in transforming immunotherapy decisions and precision oncology

IRVING, Texas, Aug. 6, 2025 /PRNewswire/ --®(ٴ: CAI), a leading, patient-centric, next-generation AI TechBio company and precision medicine pioneer, has published a new study inCommunications Medicine,a Nature portfolio journal, demonstrating that Caris' AI-based image analysis model has the potential to more accurately predict cancer biomarkers and patient survival than the conventional companion diagnostic (CDx) methods. By analyzing hematoxylin and eosin (H&E) images, the study demonstrated that Caris' AI model can improve the assessment of critical cancer biomarkers and impact patient survival outcomes in breast and colorectal cancers.

For this study, Caris' AI model analyzed data from over 35,000 patients in the Caris clinico-genomic database. In breast cancer, the AI model scored PD-L1 positive phenotype status using an H&E image alone and assessed overall survival of patients treated with pembrolizumab, achieving a hazard ratio (HR) for overall survival of 0.511 (p<0.001), compared to an HR of 0.882 (p>0.1) for traditionally scored PD-L1 IHCs, a result consistent with an almost doubling of overall survival for patients treated with pembrolizumab. In colorectal cancer, AI predicted mismatch repair deficiency (MMRd) and microsatellite instability (MSI) equivalent to traditional scoring.

"Traditional PD-L1 testing canundercall positive cases, especially near the 1% threshold," said SVP, Chief Clinical Officer and Pathologist-in-Chief at Caris. "Caris' AI model enhances predictive accuracy, integrating features from both staining methods, and exhibits superior prognostic precision compared to current biomarker assessments. Clinical adoption of this tool could improve the precision and efficiency of cancer patient evaluation and aid clinical decision making."

"This study highlights how AI can significantly improve the accuracy and efficiency of tissue sample evaluation, and down the line, this has the potential to guide immunotherapy decisions and enhance patient outcomes," said , Caris EVP and Chief Medical Officer.

The publication can be viewed in its entirety on the

About Caris Life Sciences
Caris Life Sciences®�(Caris) is a leading, patient-centric, next-generation AI TechBio company and precision medicine pioneer that is actively developing and commercializing innovative solutions to transform healthcare. Through comprehensive molecular profiling (Whole Exome and Whole Transcriptome Sequencing) and the application of advanced AI and machine learning algorithms at scale, 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 to develop the latest generation of advanced precision medicine diagnostic solutions for early detection, diagnosis, monitoring, therapy selection and drug development.

Caris was founded with the belief and vision that combining a vast set of consistently generated molecular information with robust data-driven insights could realize the potential of precision medicine for patients. 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, about Caris Life Sciences and its business. All statements other than statements of historical facts contained in this press release are forward-looking statements. 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," "supports" 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 oncology industry; future financial performance, results of operations or other operational results or metrics; development, validation and timing of future solutions; the rapidly evolving competitive environment in which we operate; third-party payer reimbursement and coverage decisions; our ability to protect and enhance our intellectual property; regulatory requirements, decisions or approvals (including the timing and conditions thereof) related to our solutions; our compliance with laws and regulations; 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 the prospectus for our initial public offering filed with the Securities and Exchange Commission on June 20, 2025, 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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FAQ

What are the key findings of Caris Life Sciences' (NASDAQ: CAI) AI study in breast cancer treatment?

The study showed that breast cancer patients identified as AI signature-positive had nearly doubled overall survival when treated with pembrolizumab, with a hazard ratio of 0.511 (p<0.001) compared to 0.882 for traditional PD-L1 testing.

How many patients were included in Caris' AI model analysis?

The AI model analyzed data from over 35,000 patients in the Caris clinico-genomic database.

What advantages does Caris' AI model offer over traditional PD-L1 testing?

The AI model shows superior prognostic precision, better predictive accuracy, and can enhance the assessment of critical cancer biomarkers, particularly near the 1% threshold where traditional PD-L1 testing often undercalls positive cases.

How effective is Caris' AI technology in colorectal cancer detection?

In colorectal cancer, the AI model successfully predicted mismatch repair deficiency (MMRd) and microsatellite instability (MSI) at levels equivalent to traditional scoring methods.

What is the potential impact of Caris' AI technology on cancer treatment?

The technology has the potential to improve the precision and efficiency of cancer patient evaluation, guide immunotherapy decisions, and ultimately enhance patient outcomes through more accurate biomarker prediction.
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