{"id":35611,"date":"2026-07-14T17:00:00","date_gmt":"2026-07-14T15:00:00","guid":{"rendered":"http:\/\/stocks-future.com\/?guid=a6926f07fb3e66f02fdaf84da4f2b2d6"},"modified":"2026-07-14T17:00:00","modified_gmt":"2026-07-14T15:00:00","slug":"agilent-receives-fda-approval-for-pd-l1-ihc-28-8-pharmdx-in-esophageal-squamous-cell-carcinoma-escc-gastric-gastroesophageal-junction-gej-and-esophageal-adenocarcinoma","status":"publish","type":"post","link":"https:\/\/stocks-future.com\/?p=35611","title":{"rendered":"Agilent Receives FDA Approval for PD-L1 IHC 28-8 pharmDx in Esophageal Squamous Cell Carcinoma (ESCC), Gastric, Gastroesophageal Junction (GEJ), and Esophageal Adenocarcinoma"},"content":{"rendered":"

\nTest enables identification of patients whose tumors express PD-L1 and who may be eligible for treatment with OPDIVO\u00ae (nivolumab) or OPDIVO QVANTIG\u00ae<\/b><\/p><\/a><\/a>

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\u2011L1 IHC 28\u20118 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\u00ae (nivolumab) or OPDIVO QVANTIG\u00ae (nivolumab and hyaluronidase\u2011nvhy), Bristol Myers Squibb\u2019s PD\u20111\u2011targeted immunotherapeutic agents. PD-L1 IHC 28-8 pharmDx is approved for exclusive use with the Agilent Autostainer Link 48<\/a> advanced staining solution.<\/p>

\nPD\u2011L1 IHC 28\u20118 pharmDx, Code SK005, is an FDA\u2011approved diagnostic aid for detecting PD\u2011L1 expression (Combined Positive Score [CPS] \u2265 1) in these tumor types for patients being considered for treatment with OPDIVO\u00ae or OPDIVO QVANTIG\u00ae. PD\u2011L1 expression is determined using CPS, which measures PD\u2011L1 staining in tumor and immune cells relative to the total number of viable tumor cells.<\/p>

\n\u201cThis FDA approval highlights the critical role of validated diagnostics in advancing precision oncology,\u201d said Majken Nielsen, vice president and general manager of Agilent\u2019s Clinical Diagnostics Division. \u201cBy expanding the indications for PD\u2011L1 IHC 28\u20118 pharmDx, we are supporting pathologists and clinicians with an FDA\u2011approved test designed to help guide treatment decisions for patients with gastric and esophageal cancers. This milestone reflects Agilent\u2019s ongoing commitment to delivering high\u2011quality diagnostics that enable confidence in patient care.\u201d<\/p>

\nGastric and esophageal cancers continue to represent a significant global health burden, with high mortality rates and limited long\u2011term 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<\/sup>. Patients with esophageal cancer have an overall five-year survival of 22%2<\/sup>. 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<\/sup>. Patients with gastric cancer have an overall 5-year survival of 38%3<\/sup>. PD\u20111\u2011 and PD\u2011L1\u2011targeted immunotherapies, including OPDIVO\u00ae, 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.<\/p>

\nPD\u2011L1 IHC 28\u20118 pharmDx was developed by Agilent in partnership with Bristol Myers Squibb as part of the clinical development program supporting OPDIVO\u00ae. Clinical studies CheckMate\u2011648 and CheckMate\u2011649 demonstrated improvements in overall survival and progression\u2011free survival in patients with ESCC, gastric, GEJ, and esophageal adenocarcinoma treated with OPDIVO\u00ae and OPDIVO QVANTIG\u00ae.<\/p>

\nWith this FDA approval, Agilent further strengthens its leadership in immunohistochemistry\u2011based diagnostics and its longstanding role as a trusted partner in drug\u2011diagnostic co\u2011development, supporting pathologists and laboratories worldwide in the delivery of precision medicine.<\/p>

\nOPDIVO\u00ae and OPDIVO QVANTIG\u00ae are registered trademarks of Bristol Myers Squibb.<\/p>

\nPD\u2011L1 IHC 28\u20118 pharmDx is manufactured by Agilent Technologies, Inc.<\/p>

\n1. 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<\/p>

\n2. 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<\/a><\/p>

\n3. 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<\/a><\/p>

\nAbout Agilent Technologies<\/b><\/p>

\nAgilent Technologies, Inc. (NYSE: A) is a global leader in analytical and clinical laboratory technologies, delivering insights and innovation that help our customers bring great science to life. Agilent\u2019s full range of solutions includes instruments, software, services, and expertise that provide trusted answers to our customers\u2019 most challenging questions. The company generated revenue of $6.95 billion in fiscal year 2025 and employs approximately 18,000 people worldwide. Information about Agilent is available at www.agilent.com<\/a>. To receive the latest Agilent news, subscribe to the Agilent Newsroom<\/a>. Follow Agilent on LinkedIn<\/a> and Facebook<\/a>.<\/p> Contacts<\/b>

\nMedia Contact<\/b>Kate Coyle\nAgilent Technologies Inc.\n+1 302-633-7490\nkate.coyle@agilent.com<\/a><\/p>","protected":false},"excerpt":{"rendered":"

Test enables identification of patients whose tumors express PD-L1 and who may be eligible for treatment with OPDIVO\u00ae (nivolumab) or OPDIVO QVANTIG\u00aeSANTA CLARA, Calif.–(BUSINESS WIRE)–Agilent Technologies Inc. (NYSE: A) today announced that it has r…<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-35611","post","type-post","status-publish","format-standard","hentry","category-infos-businesswire"],"_links":{"self":[{"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/posts\/35611","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/stocks-future.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=35611"}],"version-history":[{"count":1,"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/posts\/35611\/revisions"}],"predecessor-version":[{"id":35612,"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/posts\/35611\/revisions\/35612"}],"wp:attachment":[{"href":"https:\/\/stocks-future.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=35611"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/stocks-future.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=35611"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/stocks-future.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=35611"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}