FDA Approves First Liquid Biopsy Next-Generation Sequencing Companion Diagnostic Test

Today, the U.S. Food and Drug Administration approved the first liquid biopsy companion diagnostic that also uses next-generation sequencing (NGS) technology to identify patients with specific types of mutations of the epidermal growth factor receptor (EGFR) gene in a deadly form of metastatic non-small cell lung cancer (NSCLC). This is the first approval to combine two technologies — NGS and liquid biopsy — in one diagnostic test in order to guide treatment decisions. “Approval of a companion diagnostic that uses a liquid biopsy and leverages next-generation sequencing marks a new era for mutation testing,” said Tim Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics and Ra...