Agilent Technologies, Inc.

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Bullish +75

Agilent Technologies' Cancer Test Gets Expanded Approval From FDA

🏥 Agilent Technologies received FDA approval to expand its PD-L1 cancer test to four additional tumor types.

🔬 The expanded indications include esophageal squamous cell carcinoma, triple-negative breast cancer, cervical cancer, and gastric or gastroesophageal junction cancers.

💊 This testing helps identify patients eligible for treatment with Merck's Keytruda immunotherapy drug.

🤝 PD-L1 was originally developed by Agilent in partnership with Merck as a companion diagnostic for Keytruda.

🔄 The approval extends previous indications for non-small cell lung cancer and head and neck squamous cell carcinoma to the new Dako Omnis platform.

⚙️ Previously, those initial approved indications were only available on the Autostainer Link 48 platform.

🧬 The expansion allows laboratories to consolidate testing across more tumor types within a single Dako Omnis workflow.

📅 This news was reported by Dow Jones on June 2, 2026.

Bullish Signals
  • Agilent Technologies received FDA approval to expand the use of its PD-L1 cancer test to four additional tumor types: esophageal squamous cell carcinoma, triple-negative breast cancer, cervical cancer, and gastric or gastroesophageal junction.
  • This expansion allows labs to consolidate testing across more tumor types within a single Dako Omnis workflow, improving operational efficiency compared to previous limitations on the Autostainer Link 48 platform.
  • The approved test serves as a companion diagnostic for Merck's Keytruda, enabling identification of patients eligible for this treatment across a broader range of indications.
  • The approval builds upon Agilent's existing portfolio of FDA-approved indications for non-small cell lung cancer and head and neck squamous cell carcinoma, strengthening its position in the laboratory diagnostics market.
Risk Factors
  • The article contains no negative aspects, risks, or concerning elements; it solely reports a positive regulatory approval for expanded use of Agilent's cancer testing technology.
Full Analysis
Agilent Technologies has received FDA approval to expand the use of its PD-L1 testing technology to four additional tumor types on its Dako Omnis platform. The newly approved indications include esophageal squamous cell carcinoma, triple-negative breast cancer, cervical cancer, and gastric or gastroesophageal junction cancers. This expansion allows laboratories to consolidate testing across these new tumor types within a single workflow, in addition to the previously approved indications for non-small cell lung cancer and head and neck squamous cell carcinoma which were initially limited to the Autostainer Link 48 platform. The PD-L1 test is a companion diagnostic developed by Agilent in partnership with Merck to help identify patients who may be eligible for treatment with Merck's Keytruda immunotherapy drug. By approving the Dako Omnis platform for these additional indications, the FDA is broadening access to this diagnostic tool, enabling labs to utilize a single system for a wider range of cancer diagnoses rather than requiring separate platforms for different tumor types.