Agilent Receives FDA Approval for PD-L1 Companion Diagnostic on Dako Omnis
April 23 2020 - 8:00AM
Business Wire
Agilent Technologies Inc. (NYSE: A)
today announced that the U.S. Food and Drug Administration has
approved the company’s PD-L1 IHC 22C3 pharmDx as a companion
diagnostic (CDx) to identify patients with non-small cell lung
cancer who are appropriate for first-line monotherapy with KEYTRUDA
(pembrolizumab) on the Dako Omnis
platform.
Dako Omnis is Agilent’s fully automated, walk-away solution for
staining tumor samples that provides a flexible, high-throughput
diagnostic service integrated into the core of the laboratory
workflow.
The FDA approval of this CDx demonstrates that Agilent is
continuing to enable metastatic NSCLC patients, who previously had
few and inefficient therapy options, to gain access to first-line
treatment monotherapy with the targeted immunotherapy, KEYTRUDA,
providing new hope for patients and their families.
“We are delighted to add the first FDA approval of this
important companion diagnostic on Dako Omnis,” said Simon
Østergaard, Agilent vice president, and general manager of the
company’s pathology division. “Our PD-L1 IHC 22C3 pharmDx assay is
used by thousands of laboratories around the globe, and now
customers in the U.S. can add PD-L1 to their routine IHC workflow
on Dako Omnis.”
Thanks to extensive clinical validation on NSCLC through
concordance with PD-L1 IHC 22C3 pharmDx for Autostainer Link 48,
laboratories can implement PD-L1 testing on Dako Omnis with
complete diagnostic confidence.
KEYTRUDA is a humanized monoclonal antibody that increases the
ability of the body's immune system to help detect and fight tumor
cells. Manufactured by Merck, KEYTRUDA blocks the interaction
between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T
lymphocytes, which may affect both tumor cells and healthy
cells.
Lung cancer is the leading cause of cancer-related mortality in
the United States, with an estimated incidence of 142,000 deaths in
2019 alone. Among these cases, NSCLC accounts for nearly 85% of all
diagnoses.2
Agilent is a worldwide leader in partnering with pharmaceutical
companies to develop immunohistochemical-based diagnostics for
cancer therapy.
About Agilent Technologies
Agilent Technologies Inc. (NYSE: A) is a global leader in life
sciences, diagnostics, and applied chemical markets. Now in its
20th year as an independent company delivering insight and
innovation toward improving the quality of life, Agilent
instruments, software, services, solutions, and people provide
trusted answers to customers' most challenging questions. The
company generated revenue of $5.16 billion in fiscal 2019 and
employs 16,300 people worldwide. Information about Agilent is
available at www.agilent.com. To
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References:
1. PD-L1 IHC 223 pharmDx (Dako Omnis) [package insert]
Carpinteria, CA: Dako, Agilent Pathology Solutions, 2020.
2. Howlader N, Noone AM, Krapcho M, Miller D, Brest A, Yu M,
Ruhl J, Tatalovich Z, Mariotto A, Lewis DR, Chen HS, Feuer EJ,
Cronin KA (eds). SEER Cancer Statistics Review, 1975-2016, National
Cancer Institute. Bethesda, MD,
https://seer.cancer.gov/csr/1975_2016/, based on November 2018 SEER
data submission, posted to the SEER web site, April 2019. Accessed
December 12, 2019
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Victoria Wadsworth Agilent Technologies +1 408 553 2005 +45 2933
6980 victoria.wadsworth@agilent.com
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