Agilent Gets FDA Companion Diagnostic Approval for Dako Omnis

Oct. 13, 2021, 8:22 PM

Agilent’s Ki-67 IHC MIB-1 pharmDx gets FDA approval as an aid in identifying patients with early breast cancer at high risk of disease recurrence.

  • First IHC assay measuring Ki-67 expression to receive FDA approval in the context of treatment with Verzenio and was developed in collaboration with Eli Lilly
  • “Its approval establishes a clinically relevant standard for recurrence risk assessment in EBC so that more high-risk patients who may experience clinical benefit from treatment with Verzenio are identified,” said Sam Raha, president of Agilent’s Diagnostics and Genomics Group
  • Co. shares up 1% post-market

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