On October 8, 2026 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported that Guardant360 CDx has received CE-marking under Europe’s in Vitro Diagnostic Medical Devices Regulation as a companion diagnostic (CDx) to identify patients with estrogen receptor (ER)-positive, HER2-negative locally advanced or metastatic breast cancer who may benefit from treatment with ETCAMAH (camizestrant), AstraZeneca’s next-generation oral selective estrogen receptor degrader (SERD) and complete ER antagonist. Approval in Europe reinforces Guardant Health’s commitment to enabling practice-changing ongoing monitoring across the world’s largest healthcare markets.
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With Guardant 360 CDx, clinicians can test for ESR1 mutations in tumors through a simple blood draw, ahead of disease progression. This approach reinforces the transformative role of liquid biopsy in guiding therapy decisions earlier in a breast cancer patient’s journey. The European approval follows prior regulatory approvals of Guardant360 CDx as a companion diagnostic for ETCAMAH in the United States and Japan.
"Guardant360 CDx offers molecular insights that can support informed treatment decisions for patients with advanced breast cancer, addressing the disease before it gets out of control," said Helmy Eltoukhy, Guardant Health chairman and co-CEO. "What is even more exciting is that we see tremendous potential for this type of testing protocol to transform the treatment of other cancer types to change the future of oncology."
This approval marks a significant milestone for the company, representing the third CDx approval for ETCAMAH and the 31st CDx approval for Guardant Health. The company continues to expand the platform’s reach and increasing clinical utility.
About Guardant360 CDx
Guardant360 CDx is the first FDA-approved liquid biopsy for comprehensive genomic profiling. It detects multiple genomic alterations across all solid tumors and is approved as a companion diagnostic for therapies in non-small cell lung cancer, breast cancer, and colorectal cancer.
(Press release, Guardant Health, OCT 8, 2026, View Source [SID1234673293])