FDA approves serial liquid biopsy testing

In SERENA-6, patients who changed treatment following detection of an ESR1 mutation had a 56% lower risk of disease progression or death.

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The FDA approved Guardant360 CDx as a companion diagnostic for patients with hormone receptor-positive, HER2-negative advanced breast cancer.
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Testing with Guardant360 CDx is recommended every 3 months to detect emerging ESR1 mutations during therapy.
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The approval was based on data from the phase 3 SERENA-6 trial, which involved patients receiving aromatase inhibitors.
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Switching to camizestrant after detecting ESR1 mutations reduced the risk of disease progression or death by 56%.
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Guardant360 CDx has 29 companion diagnostic indications globally and detects multiple genomic alterations across solid tumors.

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