• Saved

June 15, 2021

Guardant 360 FDA Approval as First and Only Liquid Biopsy Companion Diagnostic for Amgen’s LUMAKRAS™ (sotorasib) KRASG12C Inhibitor for Use in Advanced Non-Small Cell Lung Cancer
®-CDx-Receives-FDA-Approval-as-First-and-Only-Liquid-Biopsy-Companion-Diagnostic-for-Amgen’s-LUMAKRAS™-sotorasib-KRASG12C-Inhibitor-for-Use-in-Advanced-Non-Small-Cell-Lung-Cancer

Guardant360® CDx Receives FDA Approval as First and Only Liquid Biopsy Companion Diagnostic for Amgen's LUMAKRAS™ (sotorasib) KRASG12C Inhibitor for Use in Advanced Non-Small Cell Lung Cancer

Guardant360® CDx Receives FDA Approval as First and Only Liquid Biopsy Companion Diagnostic for Amgen's LUMAKRAS™ (sotorasib) KRASG12C Inhibitor for Use in Advanced Non-Small Cell Lung Cancer

Source : https://www.businesswire.com/news/home/20210528005396/en/Guardant360

REDWOOD CITY, Calif.--()--Guardant Health, Inc. (Nasdaq: GH) announces that the U.S. Food and Drug Administration (FDA) has approved the Guardant360 ® CDx test as the first and only liquid biopsy companion diagnostic for tumor mutation profiling, or comprehensive genomic profiling, to identify patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who harbor the KRAS G12C mutation and may benefit from LUMAKRAS™ (sotorasib), an FDA-approved KRAS G12C inhibitor developed and manufactured by Amgen.

  • June 15, 2021
    The majority of liquid biopsy testing is done without involvement of pathology. I bet my experience is not unique. This is a loss for everyone, representing a missed opportunity for utilization efforts.
  • June 15, 2021
    Please share your thoughts on Guardant 360. In which patients do you plan to use the test?