TEST:

MI Cancer Seek™

''Caris Life Sciences®, Inc...today launched “Behind the Diagnosis,” a new campaign that spotlights patients whose care has been targeted and personalized by Caris’ comprehensive molecular profiling and AI-powered precision medicine. The inaugural story features Erika Rios, who was diagnosed prior to Caris testing, with stage 4 metastatic triple-negative breast cancer. Caris GPSai®, the company’s clinically validated tissue-of-origin AI model, available when ordering Caris MI Cancer Seek®, subsequently identified the true source of her disease as Hodgkin lymphoma, one of the most treatable cancers.''

The use of drug therapies such as imlunestrant that specifically target ESR1 mutations in advanced breast cancer cases reflects the incorporation of genetic biomarkers into routine clinical decision making...The further development of HRD and the viral onco-genes have widened the options available for a biomarker-based therapy. This chapter will provide an in-depth explanation of an Introduction to Cancer Biomarkers and new research developments.

''Caris Life Sciences®...today announced the publication of a Caris-led study in The Oncologist demonstrating the ability of the Caris Lookback Program to proactively identify previously-profiled patients who become eligible for newly approved targeted therapies.''

''Caris Life Sciences®...announced the addition of two new Caris AI Insights™ signatures included in the Caris Molecular Tumor Board Report. These signatures assess the risk of patients developing brain metastases in breast and lung cancer. The addition of these two signatures brings the total number of proprietary Caris AI insights to seven, providing deeper insights to physicians and patients.This report, available upon request when ordering MI Cancer Seek® at no additional cost, provides clinicians with additional insights across all tumor types with specific algorithms for treatment decisions for colon, breast, ovarian, pancreatic and lung cancer.''

''Caris Life Sciences®...published a study in JAMA Network Open, titled “An AI Approach to Differentiating Lung Squamous Cell Carcinoma From Metastases of Other Origins.” This study builds on the body of evidence showing the superiority of Caris’ proprietary and world-leading GPSai® algorithm over traditional diagnostic procedures in correctly diagnosing cancer types...The GPSai algorithm is included as part of MI Cancer Seek® and MI Tumor Seek® at no additional cost.''

''Caris Life Sciences®...today announced the launch of a novel, proprietary Caris AI Insights™ signature for pancreatic cancer included in the Caris Molecular Tumor Board Report. The Caris Molecular Tumor Board Report is an innovative tumor profiling report that provides an additional tumor biology resource and is available upon request with no additional tissue sampling required when ordering MI Cancer Seek®.''

''Caris Life Sciences®...today announced a new breast cancer signature included in the Caris Molecular Tumor Board Report. The Caris Molecular Tumor Board Report is an innovative research-use-only (RUO) tumor profiling report that provides an additional tumor biology resource and is available upon request when ordering MI Cancer Seek®.''

"Caris Life Sciences®...has published a study in Oncotarget validating the analytical and clinical performance of MI Cancer Seek®. This FDA-approved assay is used as a companion diagnostic (CDx) to identify cancer patients who may benefit from targeted therapies. It includes one pan-cancer and five tumor-specific indications for numerous FDA-approved therapies. MI Cancer Seek is the first and only test to combine whole exome sequencing (WES) and whole transcriptome sequencing (WTS) with FDA-approved CDx indications for solid tumor profiling in both adult and pediatric patients, marking a significant advancement in precision oncology."

The clinical and analytical validation presented herein demonstrates non-inferiority of MI Cancer Seek relative to other FDA-approved CDx tests (>97% negative and positive percent agreement), as well as its precision, sensitivity, and specificity. Accordingly, MI Cancer Seek represents a safe and effective comprehensive molecular test option supporting biomarker-directed care for oncology patients.

"Caris Life Sciences®...announced the U.S. Food and Drug Administration (FDA) has approved MI Cancer Seek™ for use as a companion diagnostic (CDx) to identify cancer patients who may benefit from treatment with targeted therapies. The assay includes one pan-cancer and five tumor-specific indications for numerous FDA-approved therapies. MI Cancer Seek 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. MI Cancer Seek is available for adults and pediatric patients, ages 1-22."