Agilent Receives European IVDR Certification for Companion Diagnostic Assay in Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

European certification for PD-L1 IHC 22C3 pharmDx to help gastric or GEJ adenocarcinoma patients for KEYTRUDA® therapy

SANTA CLARA, Calif.--(BUSINESS WIRE)-- Agilent Technologies Inc. (NYSE: A) today announced its PD-L1 IHC 22C3 pharmDx (Code SK006) assay has received European IVDR certification for the use as a Companion Diagnostic (CDx) to aid in the identification of gastric or gastroesophageal Junction (GEJ) adenocarcinoma patients who may be eligible for treatment with KEYTRUDA® (pembrolizumab)¹. PD-L1 IHC 22C3 pharmDx (Code SK006) is approved for exclusive use with the Agilent Autostainer Link 48 advanced staining solution. KEYTRUDA is an anti-PD-1 therapy developed by Merck (known as MSD outside the United States and Canada).

In addition to gastric or GEJ adenocarcinoma, PD-L1 IHC 22C3 pharmDx is IVDR certified as an aid in identifying non-small cell lung cancer (NSCLC), urothelial carcinoma, esophageal cancer, head and neck squamous cell carcinoma (HNSCC), triple-negative breast cancer (TNBC), and cervical cancer patients for treatment with KEYTRUDA. Consequently, PD-L1 IHC 22C3 pharmDx is labeled for seven cancer indications and is the only IVDR-certified CDx to identify gastric and GEJ adenocarcinoma patients for treatment with KEYTRUDA.

“Immunotherapies, such as KEYTRUDA, are critical for cancer patients,” said Nina Green, vice president and general manager of the Clinical Diagnostics Division at Agilent. “With the current European indication expansion of PD-L1 IHC 22C3 pharmDx into gastric or GEJ adenocarcinoma, pathology laboratories can now support an even broader patient population in determining their eligibility for relevant treatment options.”

Gastric cancer is a leading cause of cancer-related mortality worldwide. In Europe, gastric adenocarcinoma, typically diagnosed at an advanced stage, has a 5-year survival rate of 26%.² In 2022, more than 130,000 Europeans were diagnosed with gastric cancer.³

In Europe, KEYTRUDA, in combination with trastuzumab, fluoropyrimidine, and platinum-containing chemotherapy, is indicated for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or GEJ adenocarcinoma whose tumors express PD-L1 (CPS ≥ 1). Furthermore, KEYTRUDA, in combination with fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma whose tumors express PD-L1 (CPS ≥1).⁴

PD-L1 IHC 22C3 pharmDx was developed by Agilent in partnership with Merck (known as MSD outside the United States and Canada) as a companion diagnostic for KEYTRUDA.

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

References:
1.	PD-L1 IHC 22C3 pharmDx. Santa Clara, CA: Agilent Technologies, Inc. https://www.agilent.com/en-us/product/pharmdx/pd-l1-ihc-22c3-pharmdx/pd-l1-ihc-22c3-pharmdx-product-page
2.	Rawal, P.; Barsouk, A. Epidemiology of gastric cancer: global trends, risk factors and prevention. Prz Gastroenterol. 2019, 14 (1), 26–38.
3.	International Agency for Research on Cancer, World Health Organization. Global Cancer Observatory, Factsheet, Europe; 2022 (accessed February 16, 2023): https://gco.iarc.who.int/media/globocan/factsheets/populations/908-europe-fact-sheet.pdf
4.	Keytruda. European Medicines Agency. https://www.ema.europa.eu/en/medicines/human/EPAR/keytruda

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Source: Agilent Technologies Inc.