Agilent Companion Diagnostic Expands CE-IVD Mark in Europe to Include Cervical Cancer

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.

1. PD-L1 IHC 22C3 pharmDx [Instructions for Use]. Santa Clara, CA: Agilent Technologies, Inc. (2022).
2. Keytruda [Summary of Product Characteristics]. European Medicines Agency (2022).
3. WHO. Cervical cancer, Key facts. www.who.int/news-room/fact-sheets/detail/cervical-cancer (accessed May 09, 2022).
4. European Cancer Information System (ECIS), European Commission. Cervical cancer burden in EU-27. https://ecis.jrc.ec.europa.eu/pdf/factsheets/cervical_cancer_en-Nov_2021.pdf (accessed May 09, 2022).

About Agilent Technologies

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