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Agilent Wins FDA Approval for PD-L1 Test to Guide Bristol Myers' Opdivo Use in GI Cancers

Agilent Technologies (A) said Tuesday the US Food and Drug Administration approved its PD-L1 IHC 28-8 pharmDx assay as a companion diagnostic for Bristol Myers Squibb's Opdivo and Opdivo Qvantig. This test checks patients with throat or stomach cancers for a specific protein marker, defined as a PD-L1 score of 1 or more. If they have it, they may be eligible for treatment. The assay is approved for use with Agilent's Autostainer Link 48 platform and expands the company's precision oncology diagnostics portfolio, it added.

Agilent Technologies (A) said Tuesday the US Food and Drug Administration approved its PD-L1 IHC 28-8 pharmDx assay as a companion diagnostic for Bristol Myers Squibb's Opdivo and Opdivo Qvantig.

This test checks patients with throat or stomach cancers for a specific protein marker, defined as a PD-L1 score of 1 or more.

If they have it, they may be eligible for treatment.

The assay is approved for use with Agilent's Autostainer Link 48 platform and expands the company's precision oncology diagnostics portfolio, it added.