The US Food and Drug Administration (FDA) has approved Guardant Health’s Guardant360 CDx for tumour mutation profiling in patients with any solid malignant neoplasm (cancerous tumour).
The Guardant360 CDx is also approved as a companion diagnostic to identify non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) alterations who may benefit from treatment with Tagrisso (osimertinib).
The liquid biopsy companion diagnostic uses next-generation sequencing (NGS) technology to detect specific types of mutations of the EGFR gene in metastatic NSCLC.
