Quest Diagnostics to introduce Ki-67 IHC MIB-1 pharmDx, the first companion diagnostic for Verzenio

Quest Diagnostics, provider of diagnostic information services, has announced that it will provide clinical laboratory testing using the Ki-67 IHC MIB-1 pharmDx (Dako Omnis) immunohistochemistry companion diagnostic.

On October 13 2021, the U.S. Food and Drug Administration (FDA) approved Eli Lilly and Company's Verzenio^® (abemaciclib), in combination with endocrine therapy (tamoxifen or an aromatase inhibitor), for the adjuvant treatment of adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, early breast cancer (EBC) at high risk of recurrence and a Ki-67 score of ≥20% as determined by an FDA-approved test. Ki-67 is a marker of cellular proliferation. Verzenio is the first and only CDK4/6 inhibitor approved for this patient population.

In aligned actions, the FDA also granted pre-market approval to Ki-67 IHC MIB-1 pharmDx (Dako Omnis) from Agilent Technologies, Inc. as a companion diagnostic for Verzenio. Quest is the first laboratory to have validated the test in conjunction with Agilent. Since the validation of an IVD assay can take weeks, Quest is committed to providing the test as soon as possible, with plans to make it nationally available by the end of the month.

"The imminent addition of Ki-67 IHC MIB-1 pharmDx (Dako Omnis) testing to our oncology menu underscores our commitment to providing precision medicine innovations with potential to improve outcomes for patients with cancer," said Kristie Dolan, General Manager, Oncology Franchise, Quest Diagnostics. "It also reflects our ability to create value-producing relationships across healthcare, building on our long-standing precision medicine collaboration with Agilent."

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