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Agilent Gets FDA Approval for Breast Cancer Diagnostic

October 19, 2021

Agilent Technologies’ immunohistochemistry (IHC)-based assay, Ki-67 IHC MIB-1 pharmDx, has received premarket approval from the FDA as a companion diagnostic for Eli Lilly’s Verzenio (abemaciclib) for certain patients with high-risk early breast cancer.

The assay is used to identify patients who are at high risk of disease recurrence and for whom adjuvant treatment with Verzenio in combination with endocrine therapy would be appropriate. 

The test measures the expression of the Ki-67 antigen — a protein that is associated with cellular proliferation — in breast cancer tissue removed during biopsy.

Quest Diagnostics announced yesterday that it will provide clinical laboratory testing with the Agilent assay nationally by the end of October.

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