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

August 10, 2020 Auto Bot approval, EGFR, FDA, First, Guardant Health, Identify, Liquid Biopsy, MedTech, Non-Small Cell Lung Cancer, receives 0

Shots:

  • 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

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Medpage Today