IRVING, Texas — Caris Life Sciences® (NASDAQ: CAI), a leading, patient-centric, next-generation AI TechBio company and precision medicine pioneer, today announced the launch of a groundbreaking AI-driven molecular insight for a subset of mono-immunotherapy eligible non-small cell lung cancer (NSCLC) patients. The NSCLC immunotherapy (IO) treatment selection signature was developed to determine which patients benefit from the addition of chemotherapy versus those who are harmed by the addition of chemotherapy.
Caris Life Sciences continues to advance precision oncology by integrating multimodal real-world datasets available with its proprietary CodeAI™ platform, enabling the creation of Caris AI Insights, which utilize Whole Exome Sequencing (WES), Whole Transcriptome Sequencing (WTS), and clinical data to generate greater biological understanding and more actionable insights for physicians and patients.
NSCLC is the most common type of lung cancer and remains a leading cause of cancer-related deaths worldwide. For patients with driver-negative tumors that express high levels of PD-L1 (tumor proportion score ≥50%), first-line treatment options include immunotherapy alone or, in cases where the disease is considered more aggressive, a combination of immunotherapy and chemotherapy. While adding chemotherapy can improve outcomes for some patients, it may reduce survival for others. Traditionally, these critical treatment decisions have relied on clinical factors and physician judgment rather than underlying tumor biology. This new AI-driven signature leverages WES and WTS to help guide more precise and individualized therapy decisions. Additionally, prognostic information is provided for patients, reinforcing the need for personalized treatment strategies.
Developed using Caris’ large-scale clinico-genomic datasets, the signature leverages machine learning to identify complex molecular signatures associated with treatment response, moving beyond small panel biomarker tests. The model operates in two phases: first, it stratifies patients into higher- versus standard-risk groups; second, it predicts which patients may benefit from additional chemotherapy. This approach aims to reduce unnecessary chemotherapy exposure, improve treatment and inform more biologically guided therapy choices for NSCLC patients.
“Our new NSCLC IO signature represents an important step forward in personalizing NSCLC treatment,” said David Spetzler, MS, PhD, MBA, Caris President. “Not subjecting patients to potentially harmful chemotherapy and related toxicity is life-changing for cancer patients and represents a significant improvement in patient care. Providing physicians with this unique and proprietary molecular signature helps them make treatment decisions and is a core part of the Caris mission. This is another example of whole exome and transcriptome sequencing providing clinically actionable results that smaller panels with only hundreds of genes can’t provide.”
Caris received FDA approval in November 2024 for MI Cancer Seek, a tissue-based assay that is the first and only simultaneous WES and WTS-based assay with FDA-approved companion diagnostic (CDx) indications for molecular profiling of solid tumors.
About Caris Life Sciences
Caris Life Sciences® (Caris) is a leading, patient-centric, next-generation AI TechBio company and precision medicine pioneer actively developing and commercializing innovative solutions to transform healthcare. Through comprehensive molecular profiling (Whole Genome, Whole Exome and Whole Transcriptome Sequencing), advanced AI and machine learning, 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 for developing the latest generation of advanced precision medicine diagnostic solutions for early detection, diagnosis, monitoring, therapy selection and drug development.
Caris was founded with a vision to realize the potential of precision medicine 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. For more information please visit www.carislifesciences.com/.
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