Caris Life Sciences announced it is providing MET immunohistochemistry (IHC) testing as a standard of care for all patients with non-squamous non-small cell lung cancer (NSCLC), addressing a significant unmet need in precision oncology. The company aims to deliver deeper molecular insights that can guide more personalized treatment approaches for these patients.
"To our knowledge, Caris is the only lab in the United States that has historically and is currently offering the MET (SP44) RxDx assay for non-squamous non-small cell lung cancer," said Dr. David Spetzler, President of Caris Life Sciences. "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."
Addressing Critical Unmet Needs in Lung Cancer
Approximately 50% of patients with non-squamous NSCLC do not have a targetable gene driver mutation, creating a substantial treatment gap in this population. MET protein expression represents an important additional personalized target for these patients, potentially expanding therapeutic options beyond conventional approaches.
MET IHC testing specifically evaluates the expression of the MET protein in cancer cells. This protein plays a crucial role in cell proliferation, invasion, and survival, making it a vital biomarker for targeted therapies. Overexpression of the MET protein is associated with poor prognosis in non-squamous NSCLC, highlighting its clinical significance.
Comprehensive Molecular Profiling Approach
Caris utilizes a multi-platform diagnostic approach that combines immunohistochemistry with next-generation sequencing (NGS) to provide a comprehensive molecular profile of each patient's tumor. This integrated methodology allows for a more thorough analysis of tumor biology and enables oncologists to develop customized treatment strategies aligned with the specific molecular characteristics of a patient's cancer.
The company's comprehensive molecular profiling includes MI Cancer Seek® and Caris Assure®. In November 2024, Caris received FDA approval for MI Cancer Seek®, a tissue-based assay that is the first and only test to combine whole exome sequencing (WES) and whole transcriptome sequencing (WTS) in a single platform with FDA-approved companion diagnostic indications for molecular profiling of solid tumors.
Complementing this approach, Caris Assure® is a next-generation, blood-based assay that uniquely detects cancer-associated alterations, including somatic tumor variants, incidental clonal hematopoiesis, and incidental germline variants. This is accomplished through the sequencing of both plasma and buffy coat with WES and WTS assays.
Advancing Precision Medicine in Oncology
By implementing MET IHC testing as standard of care, Caris is positioning itself at the forefront of precision medicine in lung cancer treatment. The company's approach has the potential to improve therapeutic efficacy and enhance patients' overall quality of life through more targeted interventions.
"Caris remains committed to advancing cancer diagnostics and treatment through innovative technologies and rigorous scientific research," the company stated. "Deployment of MET immunohistochemistry testing for non-squamous non-small cell lung cancer patients underscores this commitment and highlights Caris' dedication to improving patient care and outcomes."
Future Implications for Drug Development
The standardization of MET IHC testing also has significant implications for future drug development. By establishing a robust testing infrastructure, Caris is creating a foundation for the development and approval of new targeted therapies directed at the MET pathway. This proactive approach may accelerate the translation of scientific discoveries into clinical applications, ultimately benefiting patients with limited treatment options.
As precision medicine continues to evolve in oncology, comprehensive molecular profiling techniques like those offered by Caris Life Sciences are likely to play an increasingly important role in treatment decision-making and drug development strategies for patients with non-squamous NSCLC and other cancer types.