On August 7, 2020, the Food and Drug Administration (FDA) approved the Guardant360 CDx assay (Guardant Health) 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).

The Guardant360 CDx assay is the first FDA-approved diagnostic test to combine two technologies – liquid biopsy and next-generation sequencing (NGS) – in order to guide treatment decisions. Liquid biopsy uses a blood sample to provide health care professionals with genetic information about the patient’s tumor. NGS uses large-panel genetic sequencing, or high-throughput tumor profiling, to assess tumor composition. The Guardant360 CDx assay uses NGS technology to simultaneously detect mutations in 55 tumor genes, rather than one gene at a time.

The Guardant360 CDx assay was granted a Breakthrough Device designation, in which the FDA provides intensive interaction and guidance to the company on efficient device development.

Food and Drug Administration (FDA). FDA Approves First Liquid Biopsy Next-Generation Sequencing Companion Diagnostic Test [news release]. August 7, 2020. Available at: click here. Accessed August 12, 2020.