Guardant Health secures EU CE‑mark for Guardant360 CDx as companion diagnostic for AstraZeneca’s camizestrant
Guardant Health announced that its Guardant360® CDx test received CE‑marking under the EU In‑Vitro Diagnostic Regulation. The test will serve as a companion diagnostic for AstraZeneca’s oral SERD camizestrant (ETCAMAH) in estrogen‑receptor‑positive, HER2‑negative advanced breast cancer. The approval marks the company’s 31st companion diagnostic clearance and the third for this specific drug. The announcement was made on 8 Oct 2026.
Why it matters
Guardant Health says the European approval expands the test’s market reach and could lift revenue, while AstraZeneca may benefit from broader use of camizestrant in the EU. The regulatory clearance therefore has a potentially positive impact on both companies’ sales pipelines.
Key facts
- 1Guardant360® CDx received CE‑marking under Europe’s In‑Vitro Diagnostic Medical Devices Regulation. marketscreener.com
- 2The test is a companion diagnostic for AstraZeneca’s camizestrant (ETCAMAH) in ER‑positive, HER2‑negative locally advanced or metastatic breast cancer. marketscreener.com
- 3This is Guardant Health’s 31st companion diagnostic approval. marketscreener.com
- 4It is the third CDx approval for camizestrant. marketscreener.com
- 5The announcement was released on 8 Oct 2026. tradingview.com
Summary written by AlphAI from 4 of 4 sources. Not investment advice. Figures are as stated by the linked sources.