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

Rhea-AI Summary

Agilent Technologies (NYSE: A) announced the expanded use of its PD-L1 IHC 22C3 pharmDx assay in Europe, now CE-IVD marked for identifying esophageal cancer patients eligible for KEYTRUDA treatment with a Combined Positive Score (CPS) ≥ 10. This assay supports treatment for patients with locally advanced unresectable or metastatic esophageal carcinoma. In 2020, almost 53,000 esophageal cancer cases were reported in Europe. The PD-L1 assay is crucial for enhancing diagnostic confidence as more patients qualify for anti-PD-1 therapies like KEYTRUDA.

Positive

• Expanded use of PD-L1 IHC 22C3 assay enhances market opportunities in Europe.
• The assay is CE-IVD marked, facilitating its adoption in identifying cancer patients.
• Increased patient eligibility for KEYTRUDA may boost sales of the assay and related therapeutics.

Negative

• None.

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 Agilent news, subscribe to our Newsroom. Follow Agilent on LinkedIn, Twitter, and Facebook.

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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FAQ

What is the significance of Agilent's PD-L1 IHC 22C3 assay expansion in Europe for stock A?

The expansion of the PD-L1 IHC 22C3 assay in Europe increases its market potential and supports cancer treatment, which could lead to higher revenues for Agilent.

How does the PD-L1 IHC 22C3 assay benefit patients with esophageal cancer in Europe?

The assay helps identify esophageal cancer patients who are eligible for treatment with KEYTRUDA, improving treatment outcomes.

What is the Combined Positive Score (CPS) mentioned in Agilent's press release?

The Combined Positive Score (CPS) is a measurement used to determine the level of PD-L1 expression in tumors, guiding the eligibility for KEYTRUDA treatment.

What were the statistics for esophageal cancer in Europe in 2020 mentioned in the press release?

In 2020, approximately 53,000 people were diagnosed with esophageal cancer in Europe, with over 45,000 deaths attributed to the disease.