Agilent Announces Update on PD-L1 CE-IVD in Urothelial Carcinoma

PD-L1 IHC 22C3 pharmDx Can Now Be Used as an Aid to Identify Urothelial Carcinoma Patients for Treatment With KEYTRUDA® (pembrolizumab)

SANTA CLARA, Calif.--(BUSINESS WIRE)-- Agilent Technologies Inc. (NYSE: A) today announced that its PD-L1 IHC 22C3 pharmDx assay is now labeled for an updated use in urothelial carcinoma in Europe.

Physicians in Europe can now use the assay as an aid to identify urothelial carcinoma patients who are ineligible for cisplatin and may respond to KEYTRUDA (pembrolizumab) as a first-line treatment option. KEYTRUDA is a targeted anti-PD-1 immunotherapy manufactured by Merck (known as MSD outside the United States and Canada). It is a humanized monoclonal antibody that may increase the ability of the body's immune system to help detect and fight tumor cells.

“We are pleased that PD-L1 IHC 22C3 pharmDx will help physicians identify urothelial carcinoma patients for whom KEYTRUDA may be an appropriate first-line treatment option. Being able to support the use of immuno-oncology therapeutics by bringing their associated diagnostics to market is truly encouraging,” said Sam Raha, president of Agilent's Diagnostics and Genomics Group.

Agilent is a worldwide leader in partnering with pharmaceutical companies to develop immunohistochemical-based diagnostics for cancer therapy. Agilent developed PD-L1 IHC 22C3 pharmDx in partnership with Merck. PD-L1 expression in urothelial carcinoma tissues is interpreted using Combined Positive Score (CPS). PD-L1 IHC 22C3 pharmDx also helps physicians identify non-small cell lung cancer (NSCLC) patients for treatment with KEYTRUDA. PD-L1 expression in NSCLC tissues is interpreted using Tumor Proportion Score (TPS).

About Agilent Technologies

Agilent Technologies Inc. (NYSE: A) is a global leader in life sciences, diagnostics, and applied chemical markets. With more than 50 years of insight and innovation, Agilent instruments, software, services, solutions, and people provide trusted answers to customers' most challenging questions. The company generated revenues of $4.47 billion in fiscal 2017 and employs 14,200 people worldwide. Information about Agilent is available at To receive the latest Agilent news, subscribe to our Newsroom.

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