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Guardant Health raises 2026 revenue guidance after third-quarter revenue reaches $361 million

🇺🇸 Guardant Health, Inc. (GH) · Thu 05 Nov 2026

The US diagnostics company lifted its full-year outlook to $1.36-1.37 billion as Oncology volumes grew and Shield screening tests rose to 83,000, alongside new FDA companion diagnostic approvals.

Guardant Health reported third-quarter 2026 results on 5 November, with revenue of $361.0 million. The company attributed the performance to growth in Oncology testing volume and to rising use of its Shield screening test, which reached 83,000 tests.

On the back of the quarter, Guardant raised its full-year revenue guidance. The range moves from $1.34-1.36 billion to $1.36-1.37 billion.

Among the regulatory highlights the company listed, the US Food and Drug Administration approved Guardant360 CDx as a companion diagnostic for camizestrant. The agency also approved it as a companion diagnostic for imlunestrant in combination with abemaciclib in ESR1-mutated breast cancer.

Guardant also submitted a premarket approval (PMA) application for Guardant360 Tissue. A PMA is the FDA's most stringent route for higher-risk devices, and requires evidence of safety and effectiveness.

On the market-access side, coverage for Shield has expanded to more than 80% of eligible lives, according to the company.

What it means for your team

  • Two new FDA companion diagnostic approvals for Guardant360 CDx in ESR1-mutated breast cancer link therapy decisions to a specific liquid biopsy test, which is relevant for labelling and testing-pathway planning.
  • The PMA submission for Guardant360 Tissue signals a further regulatory milestone to watch for tissue-based testing.
  • Shield coverage reaching more than 80% of eligible lives is a market-access data point for teams tracking payer adoption of blood-based screening.

Company's press release (SEC filing): Guardant Health, Inc. ↗

Article written by VigiEye from the official source (Guardant Health, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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