The U.S. Food and Drug Administration has approved the first liquid biopsy companion diagnostic, Guardant Health’s Guardant360® CDx, that 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.
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