Latest news with #DavidSpetzler
Malaysian Reserve
08-07-2025
- Health
- Malaysian Reserve
Caris Life Sciences Announces New Study Demonstrating the Power and Clinical Utility of its Caris Assure® Blood-Based Assay for Multi-Cancer Early Detection, Minimal Residual Disease and Therapy Selec
Scientific Reports study validates the first multifunctional, AI-enabled blood-based assay to offer diagnostic, prognostic and predictive utility in a single assay. IRVING, Texas, July 8, 2025 /PRNewswire/ — Caris Life Sciences® (NASDAQ: CAI), a leading, patient-centric, next-generation AI TechBio company and precision medicine pioneer, announced a landmark study published in Scientific Reports, a Nature journal, demonstrating the accuracy and clinical utility of the Caris Assure® blood-based biopsy assay across the cancer continuum. The Caris Assure® 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. Caris Assure® is currently used for therapy selection and is capable of enabling accurate early detection and highly sensitive disease monitoring. 'We designed Caris Assure® 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 David Spetzler, 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® liquid biopsy platform, powered by the Assure Blood-based Cancer Detection AI (ABCDai), was trained on over 376,000 whole exome and whole transcriptome tissue profiles and over 7,000 matched blood and tissue samples. In addition to therapy selection, the study validates the performance of Caris Assure® in: Multi-Cancer Early Detection (MCED): Achieved sensitivities of 83.1% to 95.7% across cancer stages I–IV at 99.6% specificity. Diagnostic Pathway Predictor: Accurately identified the diagnostic pathway for MCED-positive cancers using the ABCDai-GPS model. MRD and Recurrence Monitoring: Demonstrated significant predictive power for recurrence, with hazard ratios of 33.4 (p < 0.005) for MRD and 4.39 (p = 0.008) for therapeutic monitoring. Caris Assure® 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 tissue-agnostic, highly sensitive approach to cancer detection and monitoring. While Caris Assure® 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 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. 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: Corporate CommunicationsCorpComm@ Investor Relations:Narendra ChokshiSenior Vice President, Corporate Developmentnchokshi@
Associated Press
12-05-2025
- Health
- Associated Press
Caris Life Sciences Provides MET Immunohistochemistry Testing as Standard of Care for Non-Squamous Non-Small Cell Lung Cancer Patients
IRVING, Texas, May 12, 2025 /PRNewswire/ -- Caris Life Sciences ®(Caris), a leading next-generation AI TechBio company and precision medicine pioneer, performs MET Immunohistochemistry (IHC) testing as standard of care for all non-squamous non-small cell lung cancer (NSQ NSCLC) patients and is poised for future drug approvals. This advanced testing protocol aims to provide deeper insights into the molecular characteristics of NSQ NSCLC, facilitating more personalized and effective treatment strategies. Approximately 50% of NSQ NSCLCs lack a targetable gene driver mutation, making MET protein expression an important additional personalized target. Caris is addressing these challenges by leveraging the power of MET IHC testing, which evaluates the expression of the MET protein in cancer cells. This protein is known to play a crucial role in cell proliferation, invasion, and survival, making it a vital biomarker for targeted therapies. 'To our knowledge, Caris is the only lab in the US that has historically and is currently offering the MET (SP44) RxDx assay for NSQ NSCLC,' said Caris President David Spetzler, MS, PhD, MBA. 'With MET IHC testing already in place, we are poised and ready to provide a detailed molecular profile to inform targeted therapies and future drug development approvals.' Key Highlights of MET IHC Testing: Comprehensive Molecular Profiling: Caris utilizes a multi-platform approach, including immunohistochemistry (IHC) and next-generation sequencing (NGS), to provide a detailed molecular profile of NSQ NSCLC tumors. Identification of Actionable Targets: The MET IHC testing helps identify overexpression of the MET protein, which is associated with poor prognosis and can be targeted by specific therapies. Enhanced Treatment Personalization: By understanding the molecular makeup of NSQ NSCLC tumors, oncologists can tailor treatment plans to the individual needs of patients, potentially improving outcomes and quality of life. Caris remains committed to advancing cancer diagnostics and treatment through innovative technologies and rigorous scientific research. Deployment of MET IHC testing for NSQ NSCLC patients underscores this commitment and highlights Caris' dedication to improving patient care and outcomes. Caris' comprehensive molecular profile testing includes MI Cancer Seek® and Caris Assure®. Caris received FDA approval in November of 2024 for MI Cancer Seek®, a tissue-based assay which is the first and only simultaneous Whole Exome Sequencing (WES) and Whole Transcriptome Sequencing (WTS)-based assay with FDA-approved CDx indications for molecular profiling of solid tumors. Caris Assure® is a powerful blood-based assay that uniquely identifies somatic tumor, incidental clonal hematopoiesis and incidental germline variants by sequencing both plasma and buffy coat through a WTS and WES-based assay. About Caris Life Sciences Caris Life Sciences® (Caris) is a leading next-generation AI TechBio company and precision medicine pioneer that is actively developing and delivering innovative solutions to revolutionize healthcare and improve the human condition. Through comprehensive molecular profiling (Whole Exome and Whole Transcriptome Sequencing) and the application of advanced AI and machine learning algorithms, Caris has created the large-scale, multimodal database and computing capability needed to analyze and further unravel the molecular complexity of disease. This convergence of sequencing power, big data and AI technologies provides a differentiated platform to deliver the next generation of precision medicine tools for early detection, diagnosis, monitoring, therapy selection and drug development. Caris was founded with a vision to realize the potential of precision medicine in order 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. To learn more, please visit Caris Life Sciences Media: Corporate Communications [email protected] 214.294.5606 View original content to download multimedia: SOURCE Caris Life Sciences
Yahoo
12-05-2025
- Health
- Yahoo
Caris Life Sciences Provides MET Immunohistochemistry Testing as Standard of Care for Non-Squamous Non-Small Cell Lung Cancer Patients
IRVING, Texas, May 12, 2025 /PRNewswire/ -- Caris Life Sciences®(Caris), a leading next-generation AI TechBio company and precision medicine pioneer, performs MET Immunohistochemistry (IHC) testing as standard of care for all non-squamous non-small cell lung cancer (NSQ NSCLC) patients and is poised for future drug approvals. This advanced testing protocol aims to provide deeper insights into the molecular characteristics of NSQ NSCLC, facilitating more personalized and effective treatment strategies. Approximately 50% of NSQ NSCLCs lack a targetable gene driver mutation, making MET protein expression an important additional personalized target. Caris is addressing these challenges by leveraging the power of MET IHC testing, which evaluates the expression of the MET protein in cancer cells. This protein is known to play a crucial role in cell proliferation, invasion, and survival, making it a vital biomarker for targeted therapies. "To our knowledge, Caris is the only lab in the US that has historically and is currently offering the MET (SP44) RxDx assay for NSQ NSCLC," said Caris President David Spetzler, MS, PhD, MBA. "With MET IHC testing already in place, we are poised and ready to provide a detailed molecular profile to inform targeted therapies and future drug development approvals." Key Highlights of MET IHC Testing:Comprehensive Molecular Profiling: Caris utilizes a multi-platform approach, including immunohistochemistry (IHC) and next-generation sequencing (NGS), to provide a detailed molecular profile of NSQ NSCLC tumors. Identification of Actionable Targets: The MET IHC testing helps identify overexpression of the MET protein, which is associated with poor prognosis and can be targeted by specific therapies. Enhanced Treatment Personalization: By understanding the molecular makeup of NSQ NSCLC tumors, oncologists can tailor treatment plans to the individual needs of patients, potentially improving outcomes and quality of life. Caris remains committed to advancing cancer diagnostics and treatment through innovative technologies and rigorous scientific research. Deployment of MET IHC testing for NSQ NSCLC patients underscores this commitment and highlights Caris' dedication to improving patient care and outcomes. Caris' comprehensive molecular profile testing includes MI Cancer Seek® and Caris Assure®. Caris received FDA approval in November of 2024 for MI Cancer Seek®, a tissue-based assay which is the first and only simultaneous Whole Exome Sequencing (WES) and Whole Transcriptome Sequencing (WTS)-based assay with FDA-approved CDx indications for molecular profiling of solid tumors. Caris Assure® is a powerful blood-based assay that uniquely identifies somatic tumor, incidental clonal hematopoiesis and incidental germline variants by sequencing both plasma and buffy coat through a WTS and WES-based assay. About Caris Life SciencesCaris Life Sciences® (Caris) is a leading next-generation AI TechBio company and precision medicine pioneer that is actively developing and delivering innovative solutions to revolutionize healthcare and improve the human condition. Through comprehensive molecular profiling (Whole Exome and Whole Transcriptome Sequencing) and the application of advanced AI and machine learning algorithms, Caris has created the large-scale, multimodal database and computing capability needed to analyze and further unravel the molecular complexity of disease. This convergence of sequencing power, big data and AI technologies provides a differentiated platform to deliver the next generation of precision medicine tools for early detection, diagnosis, monitoring, therapy selection and drug development. Caris was founded with a vision to realize the potential of precision medicine in order 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. To learn more, please visit Caris Life Sciences Media: Corporate CommunicationsCorpComm@ View original content to download multimedia: SOURCE Caris Life Sciences
