Agilent Technologies received FDA approval for its PD-L1 IHC 28-8 pharmDx assay as a companion diagnostic to identify patients with esophageal squamous cell carcinoma (ESCC), gastric, gastroesophageal junction (GEJ), and esophageal adenocarcinoma who may be eligible for treatment with OPDIVO or OPDIVO QVANTIG. The approval allows for the use of the diagnostic to detect PD-L1 expression, specifically with a Combined Positive Score (CPS) of 1 or higher, in these tumor types. This development is critical for guiding treatment decisions in precision oncology for patients facing these specific cancers.

The PD-L1 IHC 28-8 pharmDx, Code SK005, is approved for exclusive use with the Agilent Autostainer Link 48 advanced staining solution. The assay determines PD-L1 expression by measuring staining in tumor and immune cells relative to the total number of viable tumor cells. This diagnostic aid was developed by Agilent in partnership with Bristol Myers Squibb as part of the clinical development program supporting OPDIVO.

Clinical studies CheckMate-648 and CheckMate-649 demonstrated improvements in overall survival and progression-free survival in patients with ESCC, gastric, GEJ, and esophageal adenocarcinoma treated with OPDIVO and OPDIVO QVANTIG. These therapies are PD-1-targeted immunotherapeutic agents developed by Bristol Myers Squibb.

Gastric and esophageal cancers represent a significant global health burden with high mortality rates. Esophageal cancer is the 11th most common cancer worldwide with over 510,000 new cases and is the seventh leading cause of cancer mortality, accounting for over 445,000 cancer deaths each year. Patients with esophageal cancer have an overall five-year survival of 22%. Gastric cancer is the fifth most common cancer worldwide with around 968,000 new cases and is the fifth leading cause of cancer mortality, accounting for approximately 660,000 cancer deaths each year. Patients with gastric cancer have an overall 5-year survival of 38%.

Key Cancer Statistics

"This FDA approval highlights the critical role of validated diagnostics in advancing precision oncology," said Majken Nielsen, vice president and general manager of Agilent’s Clinical Diagnostics Division. "By expanding the indications for PD-L1 IHC 28-8 pharmDx, we are supporting pathologists and clinicians with an FDA-approved test designed to help guide treatment decisions for patients with gastric and esophageal cancers. This milestone reflects Agilent’s ongoing commitment to delivering high-quality diagnostics that enable confidence in patient care."

Evercore ISI Group analyst Vijay Kumar has maintained an Outperform rating on Agilent Technologies (NYSE: A) and raised the price target to $148. The previous price target was $144. The rating reflects confidence in the company's performance prospects.

Rating and Price Target Details

The revised price target represents an increase from the prior level. The Outperform rating indicates an expectation for the stock to perform better than the broader market.