String of FDA approvals gives momentum to liquid biopsies

Following years of research and investment, liquid biopsies are steadily accumulating FDA approvals. The tests are being used in molecular profiling of solid tumors and as companion diagnostics for targeted cancer therapies.

The US FDA Approves Guardant360 CDx as the First Liquid Biopsy NGS Assay to Identify EGFR Mutations in Non-Small Cell Lung Cancer


  • The FDA has approved Guardant360 CDx as a liquid biopsy companion diagnostic that uses NGS to identify EGFR mutations in patients with metastatic NSCLC
  • The assay utilizes two technologies- i) liquid biopsy that uses a blood sample to provide HCPs with genetic information about the patient’s tumor and ii) NGS that uses large-panel genetic sequencing, allowing clinicians to better assess tumor composition
  • Today’s approval is specific to its use in identifying NSCLC patients with EGFR alterations who may benefit from AstraZeneca’s Tagrisso. The assay has also received FDA’s breakthrough device designation

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