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October 14, 2021

US FDA approves Agilent’s Ki-67 IHC MIB-1 pharmDx for early breast cancer

The assay has been developed in collaboration with Eli Lilly and Company.

The US Food and Drug Administration (FDA) has approved Agilent Technologies’s Ki-67 IHC MIB-1 pharmDx (Dako Omnis) assay as an aid in detecting patients with early breast cancer (EBC) and high risk of disease recurrence.

The assay can be used for patients for whom treatment with Eli Lilly’s Verzenio (abemaciclib), along with endocrine therapy, is being considered.

Developed in collaboration with Eli Lilly and Company, the companion diagnostic assay is claimed to be the first FDA-approved ImmunoHistoChemistry (IHC) assay to measure Ki-67 expression with regards to potential treatment with Verzenio.

Agilent stated that detecting patients with a high risk of recurrence of EBC helps to ensure they are provided with proper treatment, which could potentially improve outcomes.

Due to its association with cellular proliferation, the American Joint Committee on Cancer has recognised the Ki-67 biomarker as a Level of Evidence III for the detection of EBC.

Agilent Diagnostics and Genomics Group president Sam Raha said: “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 EBC.

“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.”

Agilent further stated that the latest FDA approval builds on its earlier successes in expanding the applicability of the biomarker analysis.

In March, Agilent agreed to acquire Resolution Bioscience, a precision oncology solutions developer, to strengthen its capabilities in next-generation sequencing (NGS)-based cancer diagnostics.

The acquisition will allow the company to gain innovative technology that could further cater to the needs of the fast-growing precision medicine market.

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