Guardant Health receives FDA approval for Guardant360 CDx

Guardant Health (GH) announced that the U.S. Food and Drug Administration, FDA, has approved the Guardant360 CDx liquid biopsy test as a companion diagnostic for Veppanu. Veppanu, jointly developed by Arvinas (ARVN) and Pfizer (PFE), is approved for the treatment of adults with estrogen receptor-positive, human epidermal growth factor receptor 2-negative, estrogen receptor 1-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy. “This latest FDA approval using Guardant360 CDx reflects where cancer care is headed using blood-based testing to detect resistance earlier and guide smarter treatment decisions,” said Helmy Eltoukhy, Guardant Health chairman and co-CEO. “By identifying ESR1 mutations with just a simple blood draw, we’re helping bring more precise, personalized options to patients when they need them most.”