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

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    "url": "https://ca.finance.yahoo.com/news/agilent-receives-fda-approval-pd-120000155.html",
    "title": "Agilent Receives FDA Approval for PD-L1 IHC 28-8 pharmDx in Esophageal Squamous Cell Carcinoma (ESCC), Gastric, Gastroesophageal Junction (GEJ), and Esophageal Adenocarcinoma - Yahoo! Finance Canada",
    "excerpt": "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., July 14, 2026 --( 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...",
    "product": "PD-L1 IHC 28-8 pharmDx",
    "summary": "Agilent Technologies received FDA approval for its PD-L1 IHC 28-8 pharmDx assay as a companion diagnostic for certain types of esophageal and gastric cancers.",
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    "article_sentence": "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."
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