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Agilent Companion Diagnostic Expands CE-IVD Mark in Europe to Include Cervical Cancer
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Agilent Technologies (NYSE: A) announced that its PD-L1 IHC 22C3 pharmDx is now CE-IVD-marked for use in cervical cancer in Europe. This diagnostic aids in identifying patients eligible for treatment with KEYTRUDA (pembrolizumab), an anti-PD-1 therapy developed by Merck. Cervical cancer is notably prevalent, with approximately 30,447 new cases in Europe in 2020. This expansion allows pathologists to access reliable testing for more patients, enhancing Agilent's position in the diagnostics market for targeted cancer therapies.
Positive
PD-L1 IHC 22C3 pharmDx is now CE-IVD-marked for cervical cancer, expanding Agilent's diagnostics portfolio.
The diagnostic aids in identifying patients eligible for KEYTRUDA treatment, potentially increasing sales.
Cervical cancer's significant prevalence underscores the necessity for this diagnostic tool.
Negative
None.
SANTA CLARA, Calif.--(BUSINESS WIRE)--
Agilent Technologies Inc. (NYSE: A) today announced that its PD-L1 IHC 22C3 pharmDx, Code SK006, is now EU CE-IVD–marked for use in cervical cancer. PD-L1 IHC 22C3 pharmDx can be used as an aid in identifying cervical cancer patients for whom treatment with KEYTRUDA® (pembrolizumab) may be appropriate.1 KEYTRUDA is an anti-PD-1 therapy developed by Merck (known as MSD outside the U.S. and Canada). In Europe, KEYTRUDA, in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumors express PD-L1 [Combined Positive Score (CPS) ≥ 1].2
PD-L1 expression is a critical biomarker for response to anti-PD-1 therapies such as KEYTRUDA whose therapeutic value is being demonstrated across a growing list of cancer types. Globally, cervical cancer is the fourth most common cancer among women,3 with approximately 30,447 new cases diagnosed in Europe in 2020.4
Sam Raha, president of Agilent’s Diagnostics and Genomics Group, discussed the impact of the updated labeling. “PD-1/PD-L1-targeted immunotherapies such as KEYTRUDA have become important cancer treatment options for a growing number of patients. With this European indication expansion of PD-L1 IHC 22C3 pharmDx into cervical cancer, pathologists have access to reliable diagnostic results, supporting even more cancer patients who could benefit from targeted therapies.”
Currently, PD-L1 IHC 22C3 pharmDx is the only CE-IVD marked companion diagnostic indicated as an aid in identifying cervical cancer patients with PD-L1 CPS ≥ 1 for treatment with KEYTRUDA. This indication expansion extends the scope of patients who can be tested to determine eligibility for KEYTRUDA, and further strengthens Agilent's leadership position as a partner in the development of IHC-based diagnostics for targeted cancer therapies.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
Agilent Technologies Inc. (NYSE: A) is a global leader in the life sciences, diagnostics, and applied chemical markets, delivering insight and innovation that advance the quality of life. Agilent’s full range of solutions includes instruments, software, services, and expertise that provide trusted answers to our customers' most challenging questions. The company generated revenue of $6.32 billion in fiscal 2021 and employs 17,000 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.
