Agilent Companion Diagnostic Expands CE-IVD Mark in Europe to Include Esophageal Cancer
August 23 2021 - 11:00AM
Business Wire
PD-L1 IHC 22C3 pharmDx can now be used as an aid to identify
esophageal cancer patients for treatment with KEYTRUDA®
(pembrolizumab)
Agilent Technologies Inc. (NYSE: A) today announced that the
company’s PD-L1 IHC 22C3 pharmDx assay has expanded its use in
Europe. The assay is now CE-IVD marked for use as an aid in
identifying esophageal cancer patients for treatment with KEYTRUDA
using Combined Positive Score (CPS) ≥ 10.1 In Europe, KEYTRUDA is
approved in combination with platinum- and fluoropyrimidine-based
chemotherapy for patients with locally advanced unresectable or
metastatic esophageal carcinoma or HER2 negative gastroesophageal
junction adenocarcinoma whose tumors express PD-L1 [Combined
Positive Score (CPS) ≥ 10].2
“PD-L1 has been established as an essential biomarker for
anti-PD-1 therapies like KEYTRUDA,” said Sam Raha, president of
Agilent’s Diagnostics and Genomics Group. “Pathologists’ confidence
in their PD-L1 test is critical, as a growing number of patients
are becoming eligible for treatment with these therapies. With
expanded use of our PD-L1 IHC 22C3 pharmDx assay, Agilent can
provide pathologists with the quality, reliability, and accuracy
they need to ensure diagnostic confidence.”
In Europe, almost 53,000 people were diagnosed with esophageal
cancer in 2020, and this type of cancer caused more than 45,000
deaths the same year.3
KEYTRUDA is a humanized monoclonal antibody that enhances the
ability of the immune system to detect and fight tumor cells.
KEYTRUDA blocks the PD-1 pathway, thereby activating T lymphocytes
that may affect both tumor cells and healthy cells.2 KEYTRUDA and
other targeted immunotherapies are changing cancer treatment, and
their therapeutic value is being realized across a growing list of
cancer types. PD-L1 IHC 22C3 pharmDx was developed by Agilent as a
companion diagnostic for KEYTRUDA in partnership with Merck (known
as MSD outside the United States and Canada).
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
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Reference: 1. PD-L1 IHC 22C3 pharmDx [package insert].
Carpinteria, CA: Dako, Agilent Pathology Solutions; 2021. 2.
Keytruda [Summary of Product Characteristics]. European Medicines
Agency; 2021. 3. World Health Organization. Global Cancer
Observatory.
https://gco.iarc.fr/today/data/factsheets/populations/908-europe-fact-sheets.pdf
(accessed August 10, 2021).
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Naomi Goumillout Agilent Technologies +1.781.266.2819
naomi.goumillout@agilent.com
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