GH

Announcements

Nothing here yet

Daily updates

• Guardant Health received European CE marking for Guardant360 CDx under the IVDR as a companion diagnostic to identify ER-positive, HER2-negative advanced or metastatic breast cancer patients who may benefit from AstraZeneca’s camizestrant (ETCAMAH).Oct 9, 2026

FDA designations

Nothing here yet

News

• Guardant Health received FDA approval for Guardant360 CDx as a companion diagnostic for HERNEXEOSJun 11, 2026
• FDA approves new Guardant360 Liquid CDx, expanding its liquid biopsy testing footprint by 100-foldMay 20, 2026
• Guardant Health received FDA approval for Guardant360 CDx as a companion diagnostic for advanced breast cancerMay 4, 2026
• Guardant Health presented real-world evidence supporting approval of ENHERTU in Japan for HER2-positive metastatic tumorsMar 30, 2026
• Guardant Health’s Shield blood-based colorectal cancer screening test became available through Quest Diagnostics’ national networkMar 10, 2026