Guardant360 CDx Wins European Approval as Companion Diagnostic for AstraZeneca's ETCAMAH
GH has more than doubled off its 52-week low of $61.
Summary
Guardant Health received CE-marking in Europe for Guardant360 CDx as a companion diagnostic for AstraZeneca's ETCAMAH (camizestrant) in advanced ER-positive, HER2-negative breast cancer. This is the third CDx approval for ETCAMAH, following prior approvals in the US and Japan, and the 31st CDx approval overall for Guardant Health. The approval expands the addressable market for Guardant360 CDx into Europe, a major oncology market, and reinforces the company's position in liquid biopsy companion diagnostics. The news follows the FDA's accelerated approval of ETCAMAH with Guardant360 CDx in September 2026, indicating continued regulatory momentum. No specific financial impact was disclosed, but the approval supports future revenue growth from companion diagnostic testing.
At the time of this announcement, GH was trading at $165.56 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $22.2B. The 52-week trading range was $61.00 to $191.05. This news item was assessed with positive market sentiment and an importance score of 7 out of 10. Source: BusinessWire.