Guardant Health's Guardant360 CDx Receives European Approval for Advanced ER-Positive Breast Cancer Diagnostic
Guardant Health, a precision oncology company, has announced that its Guardant360 CDx liquid biopsy has received CE-marking under Europe’s in Vitro Diagnostic Medical Devices Regulation. This approval designates Guardant360 CDx as a companion diagnostic (CDx) for identifying patients with estrogen receptor (ER)-positive, HER2-negative locally advanced or metastatic breast cancer. Specifically, it will help determine which patients may benefit from treatment with AstraZeneca’s ETCAMAH™ (camizestrant), a next-generation oral selective estrogen receptor degrader (SERD) and complete ER antagonist. This European approval follows prior regulatory approvals for Guardant360 CDx as a companion diagnostic for ETCAMAH in the United States and Japan. The Guardant360 CDx allows clinicians to test for ESR1 mutations in tumors through a simple blood draw, aiming to guide therapy decisions earlier in a breast cancer patient’s treatment journey. This marks Guardant Health's 31st CDx approval and the third for ETCAMAH.
