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Guardant Health Announces Landmark FDA Approval of Guardant360® CDx as Companion Diagnostic for AstraZeneca’s ETCAMAH™ (camizestrant) in Advanced Breast Cancer

Friday, September 4, 2026 BiopharmaWatch Research 1 min read
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Key Takeaway: Guardant Health has received FDA approval for its Guardant360® CDx as a companion diagnostic for AstraZeneca's ETCAMAH™ in advanced breast cancer. This approval allows for the identification of HR-positive, HER2-negative patients with ESR1 mutations who may benefit from camizestrant treatment. This marks a significant step in precision oncology for breast cancer management.
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POSITIVE FACTORS

  • FDA approval of Guardant360® CDx is a significant milestone.
  • The diagnostic tool will help identify suitable patients for ETCAMAH™ treatment.
  • This advancement supports precision oncology in breast cancer care.

Full Press Release Details

PALO ALTO, Calif.--(BUSINESS WIRE)--Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved Guardant360® CDx as a companion diagnostic (CDx) to identify patients with hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer harboring tumors with ESR1 mutations before radiographic progression who may benefit from treatment with ETCAMAH™ (camizestrant), AstraZeneca’s next-gener

Frequently Asked Questions

What is Guardant360® CDx?

Guardant360® CDx is a companion diagnostic approved to identify patients for treatment.

What type of cancer does this approval target?

The approval targets hormone receptor-positive, HER2-negative advanced breast cancer.

Who developed ETCAMAH™?

ETCAMAH™ is developed by AstraZeneca for treating advanced breast cancer.

What mutations does Guardant360® CDx identify?

It identifies tumors with ESR1 mutations in breast cancer patients.

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Tags: GH Viatris Investor Conferences Healthcare Guardant Health FDA approval ETCAMAH advanced breast cancer camizestrant
Last updated: Sep 4, 2026

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