Guardant Health receives FDA clearance for Guardant360 CDx to guide AstraZeneca's Etcamah in breast cancer

Guardant Health announced that the FDA has cleared its Guardant360 CDx test, which is designed to identify patients who may benefit from AstraZeneca's newly approved breast cancer therapy Etcamah.

The diagnostic approval comes alongside the recent FDA endorsement of Etcamah for hormone receptor positive, HER2 negative advanced breast cancer patients who have an ESR1 mutation detected during aromatase inhibitor and CDK4/6 inhibitor treatment. Use of the test is required to determine eligibility for the drug.

Guardant said the test can be repeated every three months to monitor emerging ESR1 mutations, allowing clinicians to adjust therapy before clinical or radiographic progression, a shift in biomarker testing for advanced cancer.