From the Guidelines
The Caris Life Sciences MI Profile is a comprehensive molecular testing service for solid tumors that analyzes cancer tissue (FFPE block) to identify genetic mutations, protein expression patterns, and other molecular characteristics that can guide treatment decisions, as recommended by recent guidelines such as those from ESMO 1. This test examines multiple biomarkers including gene mutations, fusions, copy number alterations, microsatellite instability, tumor mutational burden, and protein expression using various technologies like next-generation sequencing, immunohistochemistry, and in situ hybridization. The results provide oncologists with actionable information to match patients with targeted therapies, immunotherapies, or clinical trials based on their tumor's specific molecular profile. The process requires submission of a formalin-fixed paraffin-embedded (FFPE) tissue block from the patient's tumor to Caris laboratories, where the tissue undergoes multiple analyses. Key considerations in the validation of FFPE tissues include the length of formalin fixation and the age of blocks, as well as the specific specimen types and preanalytical processing, as highlighted in guidelines from the American Society for Clinical Pathology, College of American Pathologists, Association for Molecular Pathology, and the American Society of Clinical Oncology 1. This precision medicine approach helps identify potential treatment options that might not be considered with conventional testing, potentially improving outcomes by tailoring therapy to the specific molecular drivers of an individual's cancer rather than treating based solely on the cancer's location or appearance under a microscope. Some of the key features of the Caris Life Sciences MI Profile include:
- Comprehensive molecular analysis of solid tumors
- Examination of multiple biomarkers, including genetic mutations and protein expression patterns
- Use of various technologies, such as next-generation sequencing and immunohistochemistry
- Actionable information for matching patients with targeted therapies, immunotherapies, or clinical trials
- Submission of FFPE tissue block for analysis at Caris laboratories.
From the Research
Cancer Solid Tumor Molecular Intelligence MI Profile CARIS LIFE SCIENCE FFPE BLOCK
- The Caris Molecular Intelligence (CMI) profile is a comprehensive molecular profiling service that analyzes DNA, RNA, and protein from tumor tissue samples to guide therapy management 2.
- The CMI profile includes analysis of next-generation sequencing, chromogenic or fluorescent in situ hybridization, pyrosequencing, and copy number alterations for DNA; whole-transcriptome sequencing and multiplex PCR of RNA for RNA; and immunohistochemistry for protein 2.
- The CMI profile has been used to identify actionable biomarkers for patients with advanced solid tumors, including elevated PDL-1 and amplification of HER2 2.
- Formalin-fixed paraffin-embedded (FFPE) specimens can be used for comprehensive genomic profiling of solid tumors, and automated solutions are available for upstream sample processing to enable high-throughput and scalable workflows 3.
- The cost-effectiveness of CMI-guided treatment has been evaluated, and studies have shown that it can be cost-effective due to beneficial overall survival outcomes 4.
- Molecular diagnosis and targeted therapy for MET-dependent solid tumors have been developed, and high-level MET amplification and activating MET mutations or fusions are known to be drivers of oncogenesis 5.
- Tyrosine kinase inhibitors (TKIs) have emerged as major targets for drug discovery, and multiple robust and well-tolerated TKIs have been developed for the treatment of solid tumors, including EGFR, ALK, ROS1, HER2, NTRK, VEGFR, RET, MET, MEK, FGFR, PDGFR, and KIT 6.