Agilent Receives FDA Companion Diagnostic Approval for Ki-67 IHC MIB-1 pharmDx in High-Risk Early Breast Cancer
October 13 2021 - 4:16PM
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20211013006127/en/
Naomi Goumillout Agilent Technologies +1.781.266.2819
naomi.goumillout@agilent.com
Agilent Technologies (NYSE:A)
Historical Stock Chart
From Mar 2024 to Apr 2024
Agilent Technologies (NYSE:A)
Historical Stock Chart
From Apr 2023 to Apr 2024