Agilent receives FDA companion diagnostic approval for Ki-67 IHC MIB-1 pharmDx in high risk early breast cancer

Agilent Technologies

13 October 2021 - Agilent Technologies today announced its Ki-67 IHC MIB-1 pharmDx (Dako Omnis) is now FDA approved as an aid in identifying patients with early breast cancer at high risk of disease recurrence, for whom adjuvant treatment with Verzenio (abemaciclib) in combination with endocrine therapy is being considered. 

This is the 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.

Read Agilent Technologies press release

Michael Wonder

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Michael Wonder

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Cancer , Outcome , US , Diagnostic agent