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FDA approves Guardant360 CDx for ESR1 mutation testing in breast cancer
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Fusion42 · 7 September 2026 · Fusion42 review
The FDA has approved Guardant360 CDx as the first liquid biopsy companion diagnostic for identifying ESR1 mutations to guide early treatment changes in HR-positive, HER2-negative advanced breast cancer, based on the SERENA-6 trial demonstrating improved progression-free survival.
This Wire brief sits within Fusion42's coverage of Biotech.
◆ ◆ The Wire takeaway
You have an opening to develop or partner on liquid biopsy tools that guide cancer treatment earlier than imaging allows. This regulatory move makes real-time tumour evolution monitoring a frontline option, changing how you validate and sell diagnostics in oncology.
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1 source · 7 Sep 2026
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