June 21, 2024


Agilent’s Ki-67 IHC MIB-1 pharmDx Approved for Breast Cancer.

The FDA has approved Agilent Technologies’ Ki67 IHC MIB1 pharmDx (Dako Omnis) test to aid in the detection of recurrence in high-risk, early breast cancer (EBC) patients. In addition to endocrine therapy, the test can be utilized for patients who are considering treatment with Eli Lilly’s Verzenio (abemaciclib).

The accompanying diagnostic test, developed in conjunction with Eli Lilly & Company, is the first FDA-approved immunohistochemistry (IHC) test to evaluate Ki67 expression concerning possible Verzenio treatment. If there is a recurrence, this helps to ensure that they are effectively addressed, which could potentially enhance results. The American Joint Committee on Cancer has designated the biomarker Ki67 as level III evidence for the identification of EBC due to its connection with cell proliferation.

“The Agilent Ki67 IHC MIB1 pharmDx (Dako Omnis) Complementary Diagnostic Test for the Dako Omnis Advanced Stain Platform was created and evaluated to assist in the assessment of the risk of EBC recurrence,” said Sam Raha, President of Agilent Diagnostics and Genomics Group. Its approval sets a clinically acceptable criterion for evaluating the risk of recurrence in the EBC, allowing more high-risk individuals to be identified and treated with Verzenio.

Agilent further stated that the latest FDA approval builds on the company’s earlier accomplishments in broadening the scope of biomarker analysis. Agilent decided in March to buy Resolution Bioscience, a provider of precision cancer solutions, to expand its capabilities in next-generation sequencing-based cancer diagnostics (NGS). The acquisition will allow the company to obtain cutting-edge technologies that will allow it to better satisfy the demands of the rapidly expanding precision medicine sector.

FDA Approves Agilent Ki-67 IHC MIB-1 PharmDx for Early Breast Cancer. (2021, October 14). FDA approves Agilent Ki-67 IHC MIB-1 pharmDx for early breast cancer. 


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