FDA Expands Approval for Agilent’s PD-L1 Test to Four Cancer Types
FDA approves Agilent’s PD-L1 test expansion for four cancers
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Agilent Technologies has received FDA approval to expand its PD-L1 IHC 22C3 pharmDx test for use on the Dako Omnis platform, now covering esophageal squamous cell carcinoma, triple-negative breast cancer, cervical cancer, and gastric adenocarcinoma. This allows for consolidated testing across multiple cancer types.
- 01The PD-L1 IHC 22C3 pharmDx test is now approved for four additional cancer types, enhancing its utility in identifying patients eligible for Merck's KEYTRUDA.
- 02The test was previously limited to the Autostainer Link 48 platform, but can now be used on the Dako Omnis platform, streamlining workflows in pathology labs.
- 03Agilent's recent fiscal report showed revenues of $6.95 billion for 2025, with a gross profit margin of 53%.
- 04The company has consistently paid dividends for 15 years and has received positive ratings from analysts regarding its financial health.
- 05Analysts have adjusted their price targets for Agilent, with TD Cowen and RBC Capital both raising their targets to $155, reflecting strong demand and product performance.
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Agilent Technologies Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved the expanded use of its PD-L1 IHC 22C3 pharmDx diagnostic test on the Dako Omnis platform for four additional cancer types: esophageal squamous cell carcinoma, triple-negative breast cancer, cervical cancer, and gastric adenocarcinoma. This expansion allows pathology laboratories to consolidate PD-L1 testing across multiple tumor types within a single automated workflow. Previously, this test was only available on the Autostainer Link 48 platform. Agilent conducted a multisite external performance comparison study, which demonstrated inter-platform concordance for the new indications. The company reported revenues of $6.95 billion in fiscal year 2025 and has maintained a 53% gross profit margin while paying dividends consistently for 15 years. Following positive second-quarter fiscal results, several analysts have adjusted their price targets for Agilent, with TD Cowen and RBC Capital both setting targets at $155, highlighting the company’s robust performance and demand for its products.
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The approval of the PD-L1 test expansion will enhance diagnostic capabilities for multiple cancers, potentially improving treatment outcomes for patients.
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