Guardant Health Secures EU Approval for AstraZeneca Companion Diagnostic

Key Facts

1Guardant360 CDx received CE-marking in Europe as a companion diagnostic for AstraZeneca's camizestrant (ETCAMAH).

Guardant360 CDx received CE-marking in Europe as a companion diagnostic for AstraZeneca's camizestrant (ETCAMAH). Business Wire reported that the liquid biopsy test is approved to identify patients with advanced ER-positive breast cancer harboring ESR1 mutations who are eligible for the treatment.

Guardant Health (GH) shares closed at $168.33 on October 7, 2026, while AstraZeneca (AZN) closed at $160.12 on the same date. The regulatory milestone under Europe’s In Vitro Diagnostic Medical Devices Regulation marks an expansion of diagnostic reach in the European market through the partnership.