Guardant Health wins European approval for breast cancer companion diagnostic

Guardant Health (NASDAQ: GH) announced that its Guardant360 CDx liquid biopsy test has received CE-marking under Europe's In Vitro Diagnostic Medical Devices Regulation as a companion diagnostic for AstraZeneca's ETCAMAH (camizestrant), a treatment for estrogen receptor (ER)-positive, HER2-negative locally advanced or metastatic breast cancer.

The test detects ESR1 mutations in tumors through a blood draw and is intended to identify patients who may benefit from treatment with camizestrant, an oral selective estrogen receptor degrader. The European approval follows earlier regulatory clearances for the same companion diagnostic use in the United States and Japan.

According to the company's press release, this marks Guardant Health's 31st companion diagnostic approval overall and the third companion diagnostic approval specifically for ETCAMAH.

Guardant360 CDx holds FDA approval as a liquid biopsy test for comprehensive genomic profiling and is approved as a companion diagnostic for therapies in non-small cell lung cancer, breast cancer, and colorectal cancer.

"Guardant360 CDx offers molecular insights that can support informed treatment decisions for patients with advanced breast cancer," said Helmy Eltoukhy, Guardant Health chairman and co-CEO.

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