FDA Approves Guardant360 CDx Companion Diagnostic For ESR1-Mutated Breast Cancer

Guardant Health announced that the U.S. FDA approved Guardant360 CDx as a companion diagnostic (CDx) to identify patients with HR-positive, HER2-negative advanced or metastatic breast cancer who harbor tumors with eligible genomic alterations. This approval is a meaningful regulatory milestone that can support broader clinical adoption of the test in the targeted patient population. The news is likely to be supportive for sentiment around the company’s commercial prospects.