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Agilent Companion Diagnostic Expands CE-IVD Mark for PD-L1 IHC 28-8 pharmDx to Include Muscle-Invasive Urothelial Carcinoma (MIUC)

Agilent Technologies Inc. (NYSE: A) today announced CE-IVD marking in the European Union for its PD-L1 IHC 28-8 pharmDx immunohistochemical assay to extend the use of the test to patients diagnosed with muscle-invasive urothelial carcinoma (MIUC) who have tumor cell PD-L1 expression ≥ 1% for adjuvant treatment with OPDIVO® (nivolumab), a PD-1-targeted immunotherapeutic from Bristol Myers Squibb.

Urothelial carcinoma is the 10th most common cancer worldwide, with over 500,000 new cases and approximately 212,000 deaths in 2020.1 The rate of relapse with distant occurrence is approximately 50% in patients with MIUC.2

PD-L1 is a biomarker for response to anti-PD-1 therapies, including OPDIVO. The expanded use of PD-L1 IHC 28-8 pharmDx helps physicians in the EU identify MIUC patients for adjuvant treatment with OPDIVO.

When used in conjunction with PD-L1 IHC 28-8 pharmDx as a companion test, OPDIVO provides the first and only PD-1-directed treatment approach that can help reduce the risk of disease recurrence and offers new hope for patients diagnosed with MIUC.

“Agilent supports pathologists with products that provide accuracy and reliability in PD-L1 testing,” said Sam Raha, president of Agilent's Diagnostics and Genomics Group. “We are pleased that this now includes the treatment of MIUC for adjuvant treatment with OPDIVO.”

This new indication CE-marking for PD-L1 IHC 28-8 pharmDx in the EU expands the current treatment options for urothelial cancer patients to include MIUC patients whose tumor cells express PD-L1 ≥ 1% and are high-risk of recurrence after undergoing radical resection, for the adjuvant treatment with OPDIVO. The new labeling builds on Agilent's previous successes in growing the clinical applicability of therapeutic biomarker analysis, further cementing the company's position as a provider of diagnostic assays that deliver high quality and ease of implementation.



2. John Michael DiBianco, Arvin K George, Daniel Su, Piyush K Agarwal. Managing noninvasive recurrences after definitive treatment for muscle-invasive bladder cancer or high-grade upper tract urothelial carcinoma. Curr Opin Urol. 2015 Sep;25(5):468-75

About Agilent Technologies

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 To receive the latest Agilent news, please subscribe to the Agilent Newsroom. Follow Agilent on LinkedIn, Twitter, and Facebook.


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