The Ki-67 IHC MIB-1 pharmDx assay is approved for identifying patients with high-risk early breast cancer. Credit: National Cancer Institute / Unsplash.

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.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

“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.