On January 4, the U.S. Food and Drug Administration (FDA) approved FoundationOne Liquid CDx to be used as a companion diagnostic to identify patients with ROS1-positive non–small cell lung cancer (NSCLC) or NTRK fusion–positive solid tumors who do not have a tissue sample available and may be appropriate candidates for treatment with the tyrosine kinase inhibitor entrectinib. FoundationOne Liquid CDx is the first and only blood-based companion diagnostic approved for entrectinib; with this latest approval, it is now approved as a companion diagnostic for nine targeted therapies.
FoundationOne Liquid CDx is a qualitative, next-generation sequencing–based, in vitro diagnostic test for prescription use only that uses targeted high throughput hybridization-based capture technology to analyze 324 genes utilizing circulating cell-free DNA isolated from plasma derived from anticoagulated peripheral whole blood of patients with advanced cancer.
Comprehensive genomic profiling has transformed the traditional ‘one-size fits-all’ approach to cancer and is an important tool for identifying rare and hard-to-find mutations, including ROS1 and NTRK. NSCLC is the most common type of lung cancer, accounting for 80% to 85% percent of all lung cancer diagnoses; ROS1 gene fusions are seen in 1% to 2% of these NSCLC diagnoses. NTRK gene fusions are also rare, occurring in roughly 0.3% of all solid tumors; however, these can be found in many tumor types including breast, cholangiocarcinoma, colorectal, gynecologic, neuroendocrine, non–small cell lung, salivary gland, pancreatic, sarcoma, and thyroid cancers.The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.