-- Guardant Health (GH) said Monday the US Food and Drug Administration approved its Guardant360 CDx test as a companion diagnostic for Arvinas (ARVN) and Pfizer's (PFE) Veppanu for certain breast cancer patients.
The company said the blood-based test identifies ESR1 mutations in patients with advanced or metastatic estrogen receptor-positive and HER2-negative breast cancer who may be eligible for treatment with Veppanu following prior endocrine therapy.
Guardant Health said this marks its third FDA approval for an ESR1 companion diagnostic and brings the total number of approved uses for the test across cancer types to 26.
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