Agilent Receives FDA Companion Diagnostic Approval for Ki-67 IHC MIB-1 pharmDx in High-Risk Early Breast Cancer

Rhea-AI Summary

Agilent Technologies (NYSE: A) announced FDA approval for its Ki-67 IHC MIB-1 pharmDx (Dako Omnis) as a diagnostic tool for early breast cancer (EBC) patients at high risk of disease recurrence. This assay, developed in partnership with Eli Lilly, is the first to be approved for use with the drug Verzenio (abemaciclib). The approval is critical for better recurrence risk assessment, complementing traditional staging methods. This move positions Agilent as a key player in the diagnostic assay market, enhancing treatment decision-making for high-risk EBC patients.

Positive

• FDA approval of Ki-67 IHC MIB-1 pharmDx provides a new tool for assessing recurrence risk in early breast cancer.
• Collaboration with Eli Lilly enhances credibility and market reach of the diagnostic assay.
• Establishes Agilent as a standard in recurrence risk assessment, which could increase market share in diagnostics.

Negative

• None.

SANTA CLARA, Calif.--(BUSINESS WIRE)-- Agilent Technologies Inc. (NYSE: A) today announced its Ki-67 IHC MIB-1 pharmDx (Dako Omnis) is now FDA approved as an aid in identifying patients with early breast cancer (EBC) at high risk of disease recurrence, for whom adjuvant treatment with Verzenio® (abemaciclib) in combination with endocrine therapy is being considered. This is the first IHC assay measuring Ki-67 expression to receive FDA approval in the context of treatment with Verzenio and was developed in collaboration with Eli Lilly and Company.

Understanding the risk of recurrence in EBC is vital for informing disease management, as identifying patients at high risk can provide clarity for patients as well as facilitate treatment decisions to potentially improve outcomes. Conventional methods for evaluating the risk of recurrence in EBC are based on staging and are performed according to standard clinical and pathological features of the disease. However, these standard features may not capture the full risk of recurrence for individuals with EBC.

The American Joint Committee on Cancer has identified the Ki-67 biomarker as Level of Evidence III in diagnosing EBC due to its association with cellular proliferation. Ki-67 is thus an important component of comprehensive risk assessment, but it has been inconsistently applied in the past.¹

“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 early breast cancer (EBC),” said Sam Raha, president of Agilent's Diagnostics and Genomics Group. “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.”

This approval builds on Agilent's previous successes in expanding the clinical applicability of therapeutic biomarker analysis, further cementing the company's position as a provider of diagnostic assays that deliver high quality and ease of implementation.

About Agilent Technologies

Agilent is a leader in life sciences, diagnostics, and applied chemical markets, delivering innovative technology solutions that provide trusted answers to researchers’ most challenging scientific questions. The company generated revenue of $5.34 billion in fiscal year 2020 and employs 16,400 people worldwide. Information about Agilent is available at www.agilent.com. To receive the latest Agilent news, please subscribe to the Agilent Newsroom. Follow Agilent on LinkedIn, Twitter, and Facebook.

Reference: 1. Hortobagyi, G. N.; Connolly, J. L.; D'Orsi, C. J.; Edge, S. B.; Mittendorf, E. A.; Rugo, H. S.; Solin, L. J.; Weaver, D. L.; Winchester, D. J.; Giuliano, A. Eighth Edition of the AJCC Cancer Staging Manual: Breast Cancer. J. Am. Coll. Surg. 2018, 589–636.

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Naomi Goumillout

Agilent Technologies

+1.781.266.2819

naomi.goumillout@agilent.com

Source: Agilent Technologies Inc.

FAQ

What is the recent FDA approval for Agilent Technologies related to?

Agilent's recent FDA approval is for the Ki-67 IHC MIB-1 pharmDx (Dako Omnis) assay to identify early breast cancer patients at high risk for disease recurrence.

Which drug is associated with Agilent's Ki-67 IHC MIB-1 pharmDx approval?

The Ki-67 IHC MIB-1 pharmDx assay is approved for use with Verzenio (abemaciclib) in treating early breast cancer.

What does the Ki-67 assay help with in early breast cancer treatment?

The Ki-67 assay aids in evaluating the risk of disease recurrence in early breast cancer, helping to inform treatment decisions.

Who developed the Ki-67 IHC MIB-1 assay in collaboration with Agilent?

The Ki-67 IHC MIB-1 assay was developed in collaboration with Eli Lilly and Company.