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FDA Approves Agilent Technologies CDx for Breast Cancer Drug Verzenio

NEW YORK ─ The US Food and Drug Administration has granted approval to Agilent Technologies for its Ki-67 IHC MIB-1 pharmDx (Dako Omnis) assay as an aid in identifying patients with early breast cancer who are at high risk of disease recurrence and for whom adjuvant treatment with Eli Lilly's abemaciclib (Verzenio) in combination with endocrine therapy is being considered, the firm said Wednesday.

Santa Clara, California-based Agilent said its companion diagnostic test is the first FDA-approved immunohistochemistry assay to measure Ki-67 protein expression in the context of treatment with abemaciclib.

It developed the assay in collaboration with Eli Lilly, which separately also said on Wednesday that it received FDA approval for abemaciclib, combined with endocrine therapy as an adjuvant treatment for certain patients with hormone receptor (HR)-positive, HER2-negative early breast cancer.

Agilent's Ki-67 IHC MIB-1 pharmDx (Dako Omnis) companion diagnostic assay runs on its Dako Omnis advanced staining platform.