Agilent Receives FDA Approval for PD-L1 IHC 28-8 pharmDx in Esophageal Squamous Cell Carcinoma (ESCC), Gastric, Gastroesophageal Junction (GEJ), and Esophageal Adenocarcinoma

Test enables identification of patients whose tumors express PD-L1 and who may be eligible for treatment with OPDIVO® (nivolumab) or OPDIVO QVANTIG®

SANTA CLARA, Calif.--(BUSINESS WIRE)--Agilent Technologies Inc. (NYSE: A) today announced that it has received U.S. Food and Drug Administration (FDA) approval for the 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® (nivolumab) or OPDIVO QVANTIG® (nivolumab and hyaluronidase‑nvhy), Bristol Myers Squibb’s PD‑1‑targeted immunotherapeutic agents. PD-L1 IHC 28-8 pharmDx is approved for exclusive use with the Agilent Autostainer Link 48 advanced staining solution.

PD‑L1 IHC 28‑8 pharmDx, Code SK005, is an FDA‑approved diagnostic aid for detecting PD‑L1 expression (Combined Positive Score [CPS] ≥ 1) in these tumor types for patients being considered for treatment with OPDIVO® or OPDIVO QVANTIG®. PD‑L1 expression is determined using CPS, which measures PD‑L1 staining in tumor and immune cells relative to the total number of viable tumor cells.

“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.”

Gastric and esophageal cancers continue to represent a significant global health burden, with high mortality rates and limited long‑term survival for many patients. 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 year¹. Patients with esophageal cancer have an overall five-year survival of 22%². Gastric cancer is the fifth most common cancer worldwide with around 968,000 new cases and is also the fifth leading cause of cancer mortality, accounting for approximately 660,000 cancer deaths each year¹. Patients with gastric cancer have an overall 5-year survival of 38%³. PD‑1‑ and PD‑L1‑targeted immunotherapies, including OPDIVO®, have transformed treatment approaches across multiple cancer types, underscoring the importance of accurate biomarker testing to help identify patients who may benefit from these therapies.

PD‑L1 IHC 28‑8 pharmDx 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®.

With this FDA approval, Agilent further strengthens its leadership in immunohistochemistry‑based diagnostics and its longstanding role as a trusted partner in drug‑diagnostic co‑development, supporting pathologists and laboratories worldwide in the delivery of precision medicine.

OPDIVO® and OPDIVO QVANTIG® are registered trademarks of Bristol Myers Squibb.

PD‑L1 IHC 28‑8 pharmDx is manufactured by Agilent Technologies, Inc.

1. Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024;74(3):229-263. doi:10.3322/caac.21834

2. American Cancer Society Survival Rates for Esophageal Cancer. [(accessed on 11 June 2026)]; Available online: https://www.cancer.org/cancer/esophagus-cancer/detection-diagnosis-staging/survival-rates.html

3. American Cancer Society Survival Rates for Gastric Cancer. [(accessed on 11 June 2026)]; Available online: https://www.cancer.org/cancer/types/stomach-cancer/detection-diagnosis-staging/survival-rates.html

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