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Caris Life Sciences Publishes Study Showing its Multi-Layer AI-Based Tissue of Origin Predictions are Best-in-Class and Identify when Patients have been Misdiagnosed

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Caris Life Sciences (NASDAQ: CAI) has published a groundbreaking study on its enhanced Caris GPSai� platform in AACR's Cancer Research Communications Journal. The deep learning AI system, trained on over 200,000 cases, demonstrates exceptional accuracy in identifying tumor tissue origin, achieving 95.0% accuracy in non-CUP cases.

The system successfully identified tissue origin in 84.0% of CUP and 96.3% of non-CUP cases during validation across 97,820 cases. In clinical use, GPSai led to diagnosis changes in 704 patients, with 86.1% of cases impacting treatment eligibility based on Level 1 clinical evidence. Notably, 53.6% of surveyed physicians modified treatment plans based on these findings.

Caris Life Sciences (NASDAQ: CAI) ha pubblicato uno studio innovativo sulla sua piattaforma avanzata Caris GPSai� nella rivista Cancer Research Communications dell'AACR. Il sistema di intelligenza artificiale basato su deep learning, addestrato su oltre 200.000 casi, dimostra un'accuratezza eccezionale nell'identificazione dell'origine del tessuto tumorale, raggiungendo un'accuratezza del 95,0% nei casi non CUP.

Durante la validazione su 97.820 casi, il sistema ha identificato con successo l'origine del tessuto nel 84,0% dei casi CUP e nel 96,3% dei casi non CUP. Nell'uso clinico, GPSai ha portato a cambiamenti diagnostici in 704 pazienti, con un impatto sul trattamento basato su evidenze cliniche di Livello 1 nel 86,1% dei casi. In particolare, il 53,6% dei medici intervistati ha modificato i piani terapeutici in base a questi risultati.

Caris Life Sciences (NASDAQ: CAI) ha publicado un estudio innovador sobre su plataforma mejorada Caris GPSai� en la revista Cancer Research Communications de AACR. El sistema de inteligencia artificial de aprendizaje profundo, entrenado con más de 200,000 casos, demuestra una precisión excepcional para identificar el origen del tejido tumoral, alcanzando una precisión del 95,0% en casos no CUP.

El sistema identificó con éxito el origen del tejido en el 84,0% de los casos CUP y en el 96,3% de los casos no CUP durante la validación en 97,820 casos. En uso clínico, GPSai llevó a cambios en el diagnóstico en 704 pacientes, con un impacto en la elegibilidad para tratamiento basado en evidencia clínica de Nivel 1 en el 86,1% de los casos. Notablemente, el 53,6% de los médicos encuestados modificaron sus planes de tratamiento basándose en estos hallazgos.

Caris Life Sciences (NASDAQ: CAI)� AACR� Cancer Research Communications 저널에 자사� 향상� Caris GPSai� 플랫폼에 관� 획기적인 연구� 발표했습니다. 20� � 이상� 사례� 학습� 딥러� AI 시스템은 종양 조직 기원� 식별에서 뛰어� 정확도를 보여주며, �-CUP 사례에서 95.0%� 정확�� 달성했습니다.

� 시스템은 97,820건의 사례 검증에� CUP 사례� 84.0%�-CUP 사례� 96.3%에서 조직 기원� 성공적으� 식별했습니다. 임상 사용 � GPSai� 704명의 환자 진단 변경을 이끌었으�, � � 86.1%� 1단계 임상 근거� 따른 치료 적합성에 영향� 미쳤습니�. 특히, 53.6%� 설문� 참여� 의사들이 � 결과� 바탕으로 치료 계획� 수정했습니다.

Caris Life Sciences (NASDAQ : CAI) a publié une étude révolutionnaire sur sa plateforme améliorée Caris GPSai� dans la revue Cancer Research Communications de l'AACR. Le système d'IA par apprentissage profond, entraîné sur plus de 200 000 cas, démontre une précision exceptionnelle dans l'identification de l'origine des tissus tumoraux, atteignant une précision de 95,0 % pour les cas non CUP.

Le système a réussi à identifier l'origine des tissus dans 84,0 % des cas CUP et 96,3 % des cas non CUP lors de la validation sur 97 820 cas. En utilisation clinique, GPSai a conduit à des changements de diagnostic chez 704 patients, avec un impact sur l'éligibilité au traitement basé sur des preuves cliniques de niveau 1 dans 86,1 % des cas. Notamment, 53,6 % des médecins sondés ont modifié leurs plans de traitement en se basant sur ces résultats.

Caris Life Sciences (NASDAQ: CAI) hat eine bahnbrechende Studie zu seiner verbesserten Caris GPSai�-Plattform im AACR-Fachjournal Cancer Research Communications veröffentlicht. Das Deep-Learning-KI-System, trainiert an über 200.000 Fällen, zeigt eine außergewöhnliche Genauigkeit bei der Identifizierung des Tumorgewebsursprungs und erreicht eine Genauigkeit von 95,0% bei Nicht-CUP-Fällen.

Das System identifizierte während der Validierung an 97.820 Fällen erfolgreich den Gewebeursprung in 84,0% der CUP- und 96,3% der Nicht-CUP-Fälle. In der klinischen Anwendung führte GPSai bei 704 Patienten zu Diagnosenänderungen, wobei in 86,1% der Fälle die Behandlungsoptionen basierend auf Level-1-Kliniknachweisen beeinflusst wurden. Bemerkenswert ist, dass 53,6% der befragten Ärzte ihre Behandlungspläne aufgrund dieser Ergebnisse angepasst haben.

Positive
  • Achieved 95.0% accuracy in identifying tumor tissue origin in non-CUP cases
  • Successfully identified tissue origin in 84.0% of CUP and 96.3% of non-CUP cases
  • Changed diagnosis in 704 patients with 86.1% impact on treatment eligibility
  • 53.6% of surveyed physicians changed treatment plans based on findings
  • Platform trained on extensive dataset of over 200,000 cases
Negative
  • None.

Insights

Caris GPSai's deep learning tool shows 95% accuracy identifying cancer origins, directly changing patient diagnoses and treatment paths.

Caris Life Sciences has published validation data for their enhanced Caris GPSai� diagnostic tool in AACR's Cancer Research Communications Journal, demonstrating significant clinical impact. This deep learning AI system, trained on comprehensive molecular data from over 200,000 cases, classifies tumors into 90 categories with remarkable precision � 95.0% accuracy in non-CUP (Cancer of Unknown Primary) cases.

The most compelling aspect is the real-world clinical validation. During an eight-month implementation period, GPSai actually changed the diagnosis in 704 patients, with these changes supported by orthogonal evidence like imaging and molecular markers. These weren't merely academic reclassifications � they impacted treatment eligibility in 86.1% of cases based on Level 1 clinical evidence, with 53.6% of physicians surveyed changing treatment plans accordingly.

The technology represents a significant advance from traditional machine learning to deep learning approaches. By leveraging whole exome and whole transcriptome sequencing (WES/WTS), it can identify potential misdiagnoses during routine molecular profiling without requiring additional tissue samples � a critical advantage in oncology where tissue availability is often limited.

The clinical case example cited is particularly striking: a patient initially diagnosed with triple-negative breast cancer was correctly identified as having B-cell lymphoma, which would completely change treatment approach. For CUP patients specifically, who historically face poor outcomes due to diagnostic uncertainty, the tool successfully reported a tissue of origin in 84.0% of cases, potentially bringing these patients into standard treatment protocols with improved outcomes.

Caris' AI diagnostic tool demonstrates clinical utility and market differentiation by changing diagnoses and treatment paths for misdiagnosed cancer patients.

Caris Life Sciences has published compelling validation data for its AI-powered diagnostic tool that creates real differentiation in the precision oncology market. The enhanced Caris GPSai� demonstrates 95% accuracy in tumor origin identification, addressing two critical unmet needs: identifying primary sites for Cancers of Unknown Primary (CUP) and catching misdiagnosed cancers during routine molecular profiling.

The commercial potential hinges on three key metrics. First, the ability to report a tissue of origin in 84.0% of CUP cases represents a significant advance for these traditionally difficult-to-treat patients. Second, during eight months of clinical implementation, the tool changed diagnoses in 704 patients, with 86.1% of these changes impacting treatment eligibility based on Level 1 evidence. Third, and perhaps most compelling for adoption, 53.6% of surveyed physicians reported changing treatment plans based on these findings.

This technology strengthens Caris' competitive position in the molecular diagnostics market. By leveraging its extensive database of over 200,000 profiled cases for AI training, the company is creating high barriers to entry. The integration of whole exome and whole transcriptome sequencing with deep learning capabilities represents a shift from earlier machine learning approaches, potentially making competing offerings obsolete.

For payers, this tool may improve the cost-effectiveness of precision oncology by ensuring patients receive appropriate targeted therapies based on accurate diagnoses, rather than treatments for incorrectly identified cancers. The case example of reclassifying a presumed triple-negative breast cancer as B-cell lymphoma illustrates how this technology can substantially alter treatment pathways and potentially improve outcomes while avoiding ineffective therapies.

Caris GPSaiutilizes deep learning to significantly improve diagnostic accuracy for cancers of unknown primary and misclassified tumors

IRVING, Texas, Aug. 5, 2025 /PRNewswire/ --®(ٴ: CAI), a leading, patient-centric, next-generation AI TechBio company and precision medicine pioneer, recently published a study on the development and validation of Caris' latest version of Caris GPSai� in AACR's Cancer Research Communications Journal. Caris GPSai is a clinically validated deep learning multi-layer AI that leverages comprehensive whole exome and whole transcriptome sequencing (WES/WTS) to significantly improve diagnostic accuracy for cancers of unknown primary (CUP) and identify patients who have potentially misdiagnosed tumors.

This latest advancement marks a shift from traditional machine learning to a deep learning-based approach, enabling more precise prediction of tumor tissue of origin and the identification of potential misdiagnoses during routine molecular profiling, ultimately supporting more informed treatment decisions and potentially improving patient outcomes.

The enhanced Caris GPSai was trained on WES/WTS data from over 200,000 Caris-profiled cases and classifies tumors into 90 categories.The tool demonstrated 95.0% accuracy in identifying tumor tissue of origin in non-CUP cases and successfully reported a tissue of origin in 84.0% of CUP and 96.3% of non-CUP cases during retrospective (N=21,549) and prospective (N=76,271) validations.

"The latest version of GPSai, which is a part of Caris' comprehensive molecular profiling platform, represents a major advancement in precision oncology," said , Caris SVP and Chief Clinical Officer and Pathologist-in-Chief. "By leveraging deep learning and whole exome and whole transcriptome sequencing, GPSai enhances diagnostic confidence, enabling more accurate identification of primary tumor sites and supporting more personalized treatment decisions, without the need for additional tissue samples."

In clinical use over eight months, GPSai changed the diagnosis in 704 patients, supported by orthogonal evidence such as imaging and molecular markers. These diagnostic shifts impacted treatment eligibility in 86.1% of these cases based on Level 1 clinical evidence, and 53.6% of surveyed physicians reported changing treatment plans as a result, underscoring the potential of GPSai to provide meaningful influence in patient care.

"By enhancing diagnostic accuracy, GPSai empowers physicians to make more informed treatment decisions and identify the tumor type for patients with CUP and those that have been misdiagnosed," said , President of Caris. "For example, we had a case where we found a woman diagnosed with triple negative breast cancer, who actually had B-cell Lymphoma; getting the correct diagnosis had a profound effect on her life."

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 accuracy rate did Caris GPSai achieve in identifying tumor tissue origin?

Caris GPSai achieved 95.0% accuracy in identifying tumor tissue origin in non-CUP cases and successfully identified tissue origin in 84.0% of CUP and 96.3% of non-CUP cases.

How many patients had their diagnosis changed by Caris GPSai?

During eight months of clinical use, Caris GPSai changed the diagnosis in 704 patients, with changes supported by orthogonal evidence such as imaging and molecular markers.

What percentage of treatment plans were affected by Caris GPSai's findings?

86.1% of cases impacted treatment eligibility based on Level 1 clinical evidence, and 53.6% of surveyed physicians reported changing treatment plans based on GPSai's findings.

How large was the training dataset for Caris GPSai?

Caris GPSai was trained on whole exome and whole transcriptome sequencing (WES/WTS) data from over 200,000 Caris-profiled cases and can classify tumors into 90 categories.

What is the main purpose of Caris GPSai technology?

Caris GPSai is designed to improve diagnostic accuracy for cancers of unknown primary (CUP) and identify potentially misdiagnosed tumors, supporting more informed treatment decisions through AI-powered tissue origin prediction.
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