Agilent Receives FDA Approval for the PDL1 IHC 288 PharmDx Assay

Hits:19   Date: 7/15/2026

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®

 
Agilent Technologies Inc. (NYSE: A) today announced that it has received U.S. Food and Drug Administration (FDA) approval for the PDL1 IHC 288 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 hyaluronidasenvhy), Bristol Myers Squibb’s PD1targeted immunotherapeutic agents. PD-L1 IHC 28-8 pharmDx is approved for exclusive use with the Agilent Autostainer Link 48 advanced staining solution. 

PDL1 IHC 288 pharmDx, Code SK005, is an FDAapproved diagnostic aid for detecting PDL1 expression (Combined Positive Score [CPS] ≥ 1) in these tumor types for patients being considered for treatment with OPDIVO® or OPDIVO QVANTIG®. PDL1 expression is determined using CPS, which measures PDL1 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 PDL1 IHC 288 pharmDx, we are supporting pathologists and clinicians with an FDAapproved test designed to help guide treatment decisions for patients with gastric and esophageal cancers. This milestone reflects Agilent’s ongoing commitment to delivering highquality 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 longterm 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. PD1 and PDL1targeted 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. 

PDL1 IHC 288 pharmDx was developed by Agilent in partnership with Bristol Myers Squibb as part of the clinical development program supporting OPDIVO®. Clinical studies CheckMate648 and CheckMate649 demonstrated improvements in overall survival and progressionfree 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 immunohistochemistrybased diagnostics and its longstanding role as a trusted partner in drugdiagnostic codevelopment, supporting pathologists and laboratories worldwide in the delivery of precision medicine. 

OPDIVO® and OPDIVO QVANTIG® are registered trademarks of Bristol Myers Squibb. 
PDL1 IHC 288 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

About Agilent Technologies
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