Posted by Michael Wonder on 07 Aug 2020
FDA approves first liquid biopsy next generation sequencing companion diagnostic test
7 August 2020 - Today, the U.S. Food and Drug Administration approved the first liquid biopsy companion diagnostic that also uses next generation sequencing technology to identify patients with specific types of mutations of the epidermal growth factor receptor gene in a deadly form of metastatic non-small cell lung cancer.
This is the first approval to combine two technologies — next generation sequencing and liquid biopsy — in one diagnostic test in order to guide treatment decisions.
The Guardant360 CDx assay utilises two technologies.
