Agilent Technologies Gets FDA Approval For Ki-67 IHC MIB-1 PharmDx In High-Risk Early Breast Cancer

(RTTNews) - Agilent Technologies Inc. (A) Wednesday said that the U.S. Food and Drug Administration approved its Ki-67 IHC MIB-1 pharmDx (Dako Omnis) as an aid in identifying patients with early breast cancer.

The company said FDA approved Ki-67 IHC MIB-1 pharmDx as an aid in identifying patients with early breast cancer at high risk of disease recurrence, for whom adjuvant treatment with Verzenio 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 and Company.

"Agilent's Ki-67 IHC MIB-1 pharmDx (Dako Omnis) companion diagnostic assay for the Dako Omnis advanced staining platform has been designed and tested to aid in evaluating risk of recurrence in early breast cancer (EBC)," said Sam Raha, president of Agilent's Diagnostics and Genomics Group. "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."