Agilent Technologies Inc. (NYSE: A) today announced that the U.S. Food and Drug Administration has approved the company’s PD-L1 IHC 22C3 pharmDx as a companion diagnostic (CDx) to identify patients with non-small cell lung cancer who are appropriate for first-line monotherapy with KEYTRUDA (pembrolizumab) on the Dako Omnis platform.
Dako Omnis is Agilent’s fully automated, walk-away solution for staining tumor samples that provides a flexible, high-throughput diagnostic service integrated into the core of the laboratory workflow.
The FDA approval of this CDx demonstrates that Agilent is continuing to enable metastatic NSCLC patients, who previously had few and inefficient therapy options, to gain access to first-line treatment monotherapy with the targeted immunotherapy, KEYTRUDA, providing new hope for patients and their families.
“We are delighted to add the first FDA approval of this important companion diagnostic on Dako Omnis,” said Simon Østergaard, Agilent vice president, and general manager of the company’s pathology division. “Our PD-L1 IHC 22C3 pharmDx assay is used by thousands of laboratories around the globe, and now customers in the U.S. can add PD-L1 to their routine IHC workflow on Dako Omnis.”
Thanks to extensive clinical validation on NSCLC through concordance with PD-L1 IHC 22C3 pharmDx for Autostainer Link 48, laboratories can implement PD-L1 testing on Dako Omnis with complete diagnostic confidence.
KEYTRUDA is a humanized monoclonal antibody that increases the ability of the body's immune system to help detect and fight tumor cells. Manufactured by Merck, KEYTRUDA blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes, which may affect both tumor cells and healthy cells.
Lung cancer is the leading cause of cancer-related mortality in the United States, with an estimated incidence of 142,000 deaths in 2019 alone. Among these cases, NSCLC accounts for nearly 85% of all diagnoses.2
Agilent is a worldwide leader in partnering with pharmaceutical companies to develop immunohistochemical-based diagnostics for cancer therapy.
1. PD-L1 IHC 223 pharmDx (Dako Omnis) [package insert] Carpinteria, CA: Dako, Agilent Pathology Solutions, 2020.
2. Howlader N, Noone AM, Krapcho M, Miller D, Brest A, Yu M, Ruhl J, Tatalovich Z, Mariotto A, Lewis DR, Chen HS, Feuer EJ, Cronin KA (eds). SEER Cancer Statistics Review, 1975-2016, National Cancer Institute. Bethesda, MD, https://seer.cancer.gov/csr/1975_2016/, based on November 2018 SEER data submission, posted to the SEER web site, April 2019. Accessed December 12, 2019