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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.

  • By

  • Kathryn Wighton

  • September 8, 2026

  • 2 min

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  • 1

    The FDA approved Guardant360 CDx as a companion diagnostic for patients with hormone receptor-positive, HER2-negative advanced breast cancer.

  • 2

    Testing with Guardant360 CDx is recommended every 3 months to detect emerging ESR1 mutations during therapy.

  • 3

    The approval was based on data from the phase 3 SERENA-6 trial, which involved patients receiving aromatase inhibitors.

  • 4

    Switching to camizestrant after detecting ESR1 mutations reduced the risk of disease progression or death by 56%.

  • 5

    Guardant360 CDx has 29 companion diagnostic indications globally and detects multiple genomic alterations across solid tumors.

Original Source(s)

FDA approves serial liquid biopsy testing

  • by Kathryn Wighton

  • September 8, 2026

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