Personalized medicine

Matching the mutational profile of a patient's tumor with appropriate targeted agents is a goal of personalized medicine in oncology. The number of FDA-approved targeted therapies, as well as those entering clinical trials, is continually increasing. In addition, clinical trials based on molecular profiling ("Bucket Trials") are becoming widely available in community oncology practices. Molecular profiling of tumor tissues allows for comprehensive sequencing of large panels of genes to detect mutations, copy number changes and translocations. Currently, greater than 50 FDA-approved drugs target specific genetic pathways that are altered in cancer, and there are hundreds of clinical trials that are studying the association of targeted therapies in the context of specific genetic alterations. The results are rapidly being incorporated into treatment guidelines issued by the National Cancer Center Network that recommend multiplex next-generation sequencing to identify patients who are most likely to respond to newly approved drugs. The KEW Group's CancerPlex is a DNA-based next-generation sequencing test of >400 known cancer genes that includes all genes associated with FDA-approved targeted drugs, as well as drugs in clinical development. The entire coding regions of all genes in the panel are sequenced. Thus, in addition to common genetic variants, Cancerplex detects novel or rare mutations that are missed by other testing modalities. Copy number changes and translocations of ALK, RET and ROS genes are also analyzed in one comprehensive assay. Genetic findings are reported in easy to understand, clinically relevant categories based on proprietary genetic variant database with a turnaround time of 7-10 days. Utilization of the CancerPlex panel can identify actionable findings in >90% of patients.