Caris Life Sciences Announces New Study Demonstrating the Power and Clinical Utility of its Caris Assure庐 Blood-Based Assay for Multi-Cancer Early Detection, Minimal Residual Disease and Therapy Selection
Caris Life Sciences (NASDAQ: CAI) has published a landmark study in Scientific Reports validating their Caris Assure庐 blood-based biopsy assay. The breakthrough platform combines comprehensive molecular profiling of over 23,000 genes across DNA and RNA in plasma with advanced machine learning capabilities.
The study demonstrated impressive results, including 83.1% to 95.7% sensitivity across cancer stages I-IV at 99.6% specificity for Multi-Cancer Early Detection (MCED). The platform showed significant predictive power for recurrence monitoring with hazard ratios of 33.4 for MRD and 4.39 for therapeutic monitoring.
Trained on over 376,000 whole exome and transcriptome profiles and 7,000+ matched blood-tissue samples, Caris Assure庐 is currently available for therapy selection in advanced cancers, with plans to expand into early detection and monitoring applications.
Caris Life Sciences (NASDAQ: CAI) ha pubblicato uno studio innovativo su Scientific Reports che convalida il loro test bioptico Caris Assure庐 basato sul sangue. Questa piattaforma rivoluzionaria combina un profilo molecolare completo di oltre 23.000 geni su DNA e RNA nel plasma con avanzate capacit脿 di machine learning.
Lo studio ha mostrato risultati impressionanti, con una sensibilit脿 dal 83,1% al 95,7% nelle fasi I-IV del cancro e una specificit脿 del 99,6% per il Rilevamento Precoce Multi-Cancro (MCED). La piattaforma ha evidenziato un notevole potere predittivo nel monitoraggio delle recidive con hazard ratio di 33,4 per MRD e 4,39 per il monitoraggio terapeutico.
Addestrato su oltre 376.000 profili di esoma completo e trascrittoma e pi霉 di 7.000 campioni sangue-tessuto abbinati, Caris Assure庐 猫 attualmente disponibile per la selezione terapeutica nei tumori avanzati, con piani di espansione verso applicazioni di rilevamento precoce e monitoraggio.
Caris Life Sciences (NASDAQ: CAI) ha publicado un estudio pionero en Scientific Reports que valida su prueba de biopsia sangu铆nea Caris Assure庐. Esta plataforma innovadora combina un perfil molecular integral de m谩s de 23,000 genes en ADN y ARN en plasma con avanzadas capacidades de aprendizaje autom谩tico.
El estudio demostr贸 resultados impresionantes, incluyendo una sensibilidad del 83.1% al 95.7% en las etapas I-IV del c谩ncer con una especificidad del 99.6% para la Detecci贸n Temprana Multic谩ncer (MCED). La plataforma mostr贸 un poder predictivo significativo para el monitoreo de recurrencias con razones de riesgo de 33.4 para MRD y 4.39 para el monitoreo terap茅utico.
Entrenado con m谩s de 376,000 perfiles de exoma completo y transcriptoma y m谩s de 7,000 muestras emparejadas de sangre y tejido, Caris Assure庐 est谩 disponible actualmente para la selecci贸n de terapias en c谩nceres avanzados, con planes de expandirse a aplicaciones de detecci贸n temprana y monitoreo.
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Caris Life Sciences (NASDAQ : CAI) a publi茅 une 茅tude majeure dans Scientific Reports validant leur test de biopsie sanguine Caris Assure庐. Cette plateforme r茅volutionnaire combine un profilage mol茅culaire complet de plus de 23 000 g猫nes sur l鈥橝DN et l鈥橝RN dans le plasma avec des capacit茅s avanc茅es d鈥檃pprentissage automatique.
L鈥櫭﹖ude a d茅montr茅 des r茅sultats impressionnants, notamment une sensibilit茅 de 83,1 % 脿 95,7 % selon les stades I 脿 IV du cancer avec une sp茅cificit茅 de 99,6 % pour la d茅tection pr茅coce multi-cancers (MCED). La plateforme a montr茅 un pouvoir pr茅dictif significatif pour la surveillance des r茅cidives avec des risques relatifs de 33,4 pour la MRD et de 4,39 pour la surveillance th茅rapeutique.
Form茅 sur plus de 376 000 profils d鈥檈xome complet et de transcriptome ainsi que sur plus de 7 000 茅chantillons sang-tissu appari茅s, Caris Assure庐 est actuellement disponible pour la s茅lection th茅rapeutique dans les cancers avanc茅s, avec des projets d鈥檈xtension vers des applications de d茅tection pr茅coce et de surveillance.
Caris Life Sciences (NASDAQ: CAI) hat eine bahnbrechende Studie in Scientific Reports ver枚ffentlicht, die ihren Caris Assure庐 blutbasierten Biopsietest validiert. Die innovative Plattform kombiniert umfassendes molekulares Profiling von 眉ber 23.000 Genen in DNA und RNA im Plasma mit fortschrittlichen Machine-Learning-F盲higkeiten.
Die Studie zeigte beeindruckende Ergebnisse, darunter eine Sensitivit盲t von 83,1 % bis 95,7 % 眉ber die Krebsstadien I-IV bei 99,6 % Spezifit盲t f眉r die Multi-Cancer-Fr眉herkennung (MCED). Die Plattform zeigte eine signifikante Vorhersagekraft f眉r das Rezidivmonitoring mit Hazard Ratios von 33,4 f眉r MRD und 4,39 f眉r die therapeutische 脺berwachung.
Trainiert mit 眉ber 376.000 vollst盲ndigen Exom- und Transkriptomprofilen sowie mehr als 7.000 gepaarten Blut-Gewebe-Proben ist Caris Assure庐 derzeit f眉r die Therapieauswahl bei fortgeschrittenen Krebserkrankungen verf眉gbar und plant eine Erweiterung auf Fr眉h颅erkennung und Monitoring-Anwendungen.
- Revolutionary single assay combining Whole Exome and Whole Transcriptome Sequencing with AI
- High accuracy with 83.1-95.7% sensitivity and 99.6% specificity for cancer detection
- Strong predictive power for recurrence monitoring (hazard ratio 33.4, p < 0.005)
- Extensive AI training on 376,000+ molecular profiles and 7,000+ matched samples
- No prior tissue biopsy requirement, enabling broader accessibility
- Currently limited to therapy selection in advanced cancers only
- Still pursuing reimbursement and regulatory approvals for expanded applications
Insights
Caris' blood-based assay shows exceptional performance across cancer management spectrum, positioning it as a potentially transformative diagnostic tool.
Caris Life Sciences has published a landmark validation study demonstrating the robust performance of their Caris Assure庐 blood-based assay. This represents a significant advancement in liquid biopsy technology, combining whole exome sequencing and whole transcriptome sequencing with advanced AI to analyze all 23,000+ genes from both plasma and buffy coat samples.
The technical specifications are particularly impressive. The platform achieved
What sets this platform apart is its versatility. While most liquid biopsy tests target specific applications (early detection OR therapy selection OR MRD monitoring), Caris has developed a single platform capable of supporting the entire cancer care continuum. The extensive training on 376,000 tissue profiles and 7,000 matched blood-tissue samples suggests robust algorithm development.
The tissue-agnostic approach eliminates the need for prior tissue biopsies, potentially streamlining diagnostic workflows and reducing invasive procedures. While currently commercially available only for therapy selection in advanced cancers, the validation of early detection and MRD capabilities positions Caris to expand clinical applications pending regulatory approval and reimbursement.
This multi-functional approach could disrupt the fragmented diagnostic market by offering a unified platform for detection, monitoring, and treatment guidance, potentially improving clinical outcomes while simplifying the diagnostic journey for both patients and clinicians.
Scientific Reports study validates the first multifunctional, AI-enabled blood-based assay to offer diagnostic, prognostic and predictive utility in a single assay.
The Caris Assure庐聽platform is a breakthrough single assay that combines comprehensive, highly sophisticated molecular profiling of all 23,000+ genes across DNA and RNA in plasma, setting a new blood-based testing standard and revolutionizing management of the cancer care journey. Additionally, Caris sequences DNA in the "buffy coat," the layer of centrifuged blood between the red blood cells and plasma, which contains white blood cells and platelets. Caris Assure combines Whole Exome Sequencing (WES) and Whole Transcriptome Sequencing (WTS) with advanced machine learning on a single platform.聽Caris Assure庐 is currently used for therapy selection and is capable of enabling accurate early detection and highly sensitive disease monitoring.
"We designed Caris Assure庐 to be more than a liquid biopsy test. This assay takes advantage of advanced sequencing and computing technology to capture genetic information available from the whole exome and whole transcriptome from the tumor material circulating in the blood and DNA from the patient's white blood cells," said , MS, PhD, MBA, President of Caris. "This enables us to provide a very comprehensive individualized picture of a patient's specific disease state. This is the first time so much molecular information has been available from a single blood test, allowing for increased accuracy and additional insights to inform physicians in helping to make cancer care decisions."
The Caris Assure庐聽liquid biopsy platform, powered by the Assure Blood-based Cancer Detection AI (ABCDai), was trained on over聽376,000 whole exome and whole transcriptome tissue profiles聽and聽over 7,000 matched blood and tissue samples. In addition to therapy selection, the study validates the performance of Caris Assure庐听颈苍:
- Multi-Cancer Early Detection (MCED):聽Achieved sensitivities of聽
83.1% to95.7% 聽across cancer stages I鈥揑V at聽99.6% specificity. - Diagnostic Pathway Predictor:聽Accurately identified the diagnostic pathway for MCED-positive cancers using the ABCDai-GPS model.
- MRD and Recurrence Monitoring:聽Demonstrated significant predictive power for recurrence, with hazard ratios of聽33.4 (p < 0.005)聽for MRD and聽4.39 (p = 0.008)聽for therapeutic monitoring.
Caris Assure庐聽does not require a prior tissue biopsy. Instead, its AI model identifies tumor-derived signals based on patterns learned from hundreds of thousands of tumors. This enables a聽tissue-agnostic, highly sensitive approach to cancer detection and monitoring.
While Caris Assure庐聽is currently commercially available for therapy selection in advanced cancers, this study lays the groundwork for expanding into early detection, MRD and therapeutic monitoring. Caris is actively pursuing reimbursement and regulatory pathways to bring these applications to market.
"This is more than a validation study; it is a blueprint for the future of cancer diagnostics," added Spetzler. "Our goal is to create a seamless ecosystem where patients and clinicians can rely on one platform throughout the entire cancer journey."
About Caris Life Sciences聽
Caris Life Sciences庐 (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
The Scientific Report study is available on .
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. Statements about the performance and accuracy of Caris Assure discussed in this press release are based on testing and analysis to date, as reflected in the publication discussed, and future results and performance may differ materially from these findings. 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" 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:
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214.294.5606
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