Agilent’s PD-L1 test gains European certification for cancer therapy

SANTA CLARA, Calif. - Agilent Technologies Inc. (NYSE: A), a $29.3 billion market cap company with a robust 54% gross profit margin, has announced that its PD-L1 IHC 22C3 pharmDx assay has received European IVDR certification for use as a Companion Diagnostic (CDx). This certification facilitates the identification of patients with gastric or gastroesophageal junction (GEJ) adenocarcinoma who may benefit from KEYTRUDA® (pembrolizumab), an anti-PD-1 therapy developed by Merck. According to InvestingPro analysis, Agilent maintains a "GOOD" financial health score, demonstrating strong operational stability.

The PD-L1 IHC 22C3 pharmDx, now labeled for seven cancer indications, is the only IVDR-certified CDx for identifying gastric and GEJ adenocarcinoma patients for KEYTRUDA treatment. The assay, developed by Agilent in partnership with Merck, is approved for use exclusively with Agilent’s Autostainer Link 48 advanced staining solution. Currently trading near its 52-week low, Agilent has demonstrated resilience through consistent dividend payments for 14 consecutive years. For detailed analysis and additional insights, access the comprehensive Pro Research Report available on InvestingPro.

According to Agilent, the expansion of the PD-L1 IHC 22C3 pharmDx’s indication to include gastric or GEJ adenocarcinoma will enable pathology laboratories across Europe to support a broader patient population in determining eligibility for relevant treatment options. Gastric cancer remains a leading cause of cancer-related mortality worldwide, with a 5-year survival rate of 26% in Europe. In 2022, over 130,000 Europeans were diagnosed with this disease.

KEYTRUDA is currently indicated in Europe for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or GEJ adenocarcinoma whose tumors express PD-L1, in combination with other specified chemotherapies.

This certification represents a significant step in providing access to targeted immunotherapies for patients suffering from these types of cancer. Agilent, a global leader in analytical and clinical laboratory technologies, emphasizes its commitment to delivering solutions that help in the fight against cancer. Based on InvestingPro’s Fair Value analysis, the stock currently appears undervalued, with strong fundamentals including sufficient cash flows to cover interest payments and moderate debt levels. The information in this article is based on a press release statement from Agilent Technologies.

In other recent news, Agilent Technologies reported a strong start to 2025, surpassing Wall Street’s expectations in its Q1 earnings report. The company achieved an earnings per share (EPS) of $1.31, exceeding the forecast of $1.27, while revenue reached $1.68 billion, slightly above the anticipated $1.67 billion. Stifel analysts maintained a Buy rating for Agilent, noting the company’s first-quarter performance slightly exceeded consensus estimates on both revenue and earnings, with a price target set at $151.00. Additionally, Agilent’s PD-L1 IHC 28-8 pharmDx kit gained EU approval for new uses, enhancing treatment options for patients with early-stage non-small cell lung cancer and previously untreated advanced melanoma. The company also played a significant role in the FDA approval of Autolus Therapeutics’ CAR T therapy, AUCATZYL®, by providing its xCELLigence Real-Time Cell Analysis technology. Furthermore, Agilent announced the upcoming resignation of board member Heidi Kunz, effective May 21, 2025, with the company expressing gratitude for her contributions. These developments highlight Agilent’s ongoing contributions to scientific innovation and its strategic positioning in the market.

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