European Approval Expands Liquid Biopsy Use in Advanced Breast Cancer Testing

Estrogen receptor-positive (ER+), HER2-negative advanced breast cancer may require molecular testing to guide treatment selection, with blood-based assays offering a way to identify tumor mutations that can inform therapy decisions. Supporting this approach, a newly approved liquid biopsy test now provides companion diagnostic testing in Europe for a next-generation oral selective estrogen receptor degrader.

Guardant Health’s Guardant360 CDx has received CE marking under Europe’s In Vitro Diagnostic Medical Devices Regulation (IVDR) as a companion diagnostic (CDx) for AstraZeneca’s ETCAMAH (camizestrant). The test is intended to identify patients with ER-positive, HER2-negative locally advanced or metastatic breast cancer who may benefit from ETCAMAH, a next-generation oral selective estrogen receptor degrader (SERD) and complete ER antagonist. Clinicians can use Guardant360 CDx to test for ESR1 mutations in tumors through a simple blood draw ahead of disease progression.

The company notes that Guardant360 CDx is the first U.S. Food and Drug Administration (FDA)-approved liquid biopsy for comprehensive genomic profiling. The assay detects multiple genomic alterations across solid tumors and is approved as a companion diagnostic for selected therapies in non-small cell lung cancer, breast cancer, and colorectal cancer. The latest European approval further expands its regulatory use as a companion diagnostic for ETCAMAH, following previous approvals for the therapy in the United States and Japan.

The European CE marking represents the third CDx approval for ETCAMAH. It also marks the 31st CDx approval for Guardant Health. The approval expands the platform’s reach and adds to its clinical utility in oncology testing.

“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. 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,” said Helmy Eltoukhy, Guardant Health chairman and co-CEO.

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