{"id":946922,"date":"2026-03-26T10:00:34","date_gmt":"2026-03-26T14:00:34","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/agilent-receives-fda-approval-for-pd-l1-ihc-22c3-pharmdx-in-esophageal-or-gastroesophageal-junction-gej-carcinoma\/"},"modified":"2026-03-26T10:00:34","modified_gmt":"2026-03-26T14:00:34","slug":"agilent-receives-fda-approval-for-pd-l1-ihc-22c3-pharmdx-in-esophageal-or-gastroesophageal-junction-gej-carcinoma","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/agilent-receives-fda-approval-for-pd-l1-ihc-22c3-pharmdx-in-esophageal-or-gastroesophageal-junction-gej-carcinoma\/","title":{"rendered":"Agilent Receives FDA Approval for PD-L1 IHC 22C3 pharmDx in Esophageal or Gastroesophageal Junction (GEJ) Carcinoma"},"content":{"rendered":"

<\/p>\n

Agilent Receives FDA Approval for PD-L1 IHC 22C3 pharmDx in Esophageal or Gastroesophageal Junction (GEJ) Carcinoma<\/b><\/p>\n

\nTest enables identification of patients whose tumors express PD-L1 for potential treatment with KEYTRUDA\u00ae (pembrolizumab)1, 2<\/sup><\/p>\n

SANTA CLARA, Calif.–(BUSINESS WIRE<\/a>)–Agilent Technologies Inc.<\/a> (NYSE: A)today announced that it has received U.S. Food and Drug Administration (FDA) approval for PD-L1 IHC 22C3 pharmDx, Code SK006, as a companion diagnostic to aid in identifying patients with esophageal or gastroesophageal junction (GEJ) carcinoma who may be eligible for treatment with KEYTRUDA\u00ae (pembrolizumab), Merck\u2019s anti-PD-1 therapy.<\/p>\n

\nPD-L1 IHC 22C3 pharmDx, Code SK006, is the only FDA-approved companion diagnostic indicated to identify patients with esophageal or GEJ carcinoma whose tumors express PD-L1 (Combined Positive Score (CPS) \u2265 1) who may be eligible for treatment with KEYTRUDA. This approval marks the eighth FDA approved companion diagnostic indication currently available for PD-L1 IHC 22C3 pharmDx, Code SK006, for use with KEYTRUDA.<\/p>\n

\n\u201cWith the expanded FDA approval of PD-L1 IHC 22C3 pharmDx in esophageal or GEJ carcinoma, Agilent is proud to support clinicians in identifying patients eligible for treatment with KEYTRUDA,\u201d said Nina Green, vice-president and general manager of Agilent\u2019s Clinical Diagnostics Division. \u201cThis milestone reinforces Agilent\u2019s commitment to advancing precision medicine and underscores its leadership in delivering trusted companion diagnostics that help enable treatment with anti-PD-1 therapies.\u201d<\/p>\n

\nIn addition to esophageal or GEJ carcinoma, PD-L1 IHC 22C3 pharmDx, Code SK006, is also indicated to help physicians identify patients with non-small cell lung cancer (NSCLC), esophageal squamous cell carcinoma (ESCC), cervical cancer, head and neck squamous cell carcinoma (HNSCC), triple-negative breast cancer (TNBC), gastric or GEJ adenocarcinoma, and epithelial ovarian, fallopian tube, or primary peritoneal carcinoma (EOC) who may benefit from treatment with KEYTRUDA.<\/p>\n

\nKEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation in combination with platinum- and fluoropyrimidine-based chemotherapy for patients with tumors that express PD-L1 (CPS \u2265 1).<\/p>\n

\nIn 2025, esophageal cancer caused approximately 16,250 deaths in the United States, with a 5-year relative survival rate of 21.9 percent.3<\/sup><\/p>\n

\nPD-L1 IHC 22C3 pharmDx, Code SK006, was developed by Agilent in partnership with Merck (known as MSD outside the United States and Canada) as a companion diagnostic for KEYTRUDA.<\/p>\n

\nKEYTRUDA\u00ae (pembrolizumab) is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.<\/p>\n

\nReferences:<\/p>\n

    \n
  1. \nPD-L1 IHC 22C3 pharmDx, Code SK006 [Instructions for Use]. Santa Clara, CA: Agilent Technologies, Inc.; 2026.<\/p>\n<\/li>\n
  2. \nKEYTRUDA\u00ae (pembrolizumab) Merck Sharp & Dohme LLC, Rahway, NJ, USA; 2026.<\/p>\n<\/li>\n
  3. \nNational Cancer Institute. https:\/\/seer.cancer.gov\/statfacts\/html\/esoph.html<\/a>, accessed 13 January 2026.<\/p>\n<\/li>\n<\/ol>\n

    About Agilent Technologies<\/i><\/b><\/p>\n

    Agilent 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’ 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 <\/i>www.agilent.com<\/i><\/a>. To receive the latest Agilent news, subscribe to the <\/i>Agilent Newsroom<\/i><\/a>. Follow Agilent on <\/i>LinkedIn<\/i><\/a> and <\/i>Facebook<\/i><\/a>.<\/i><\/p>\n

    \"\"<\/p>\n

    View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20260326909115\/en\/<\/a><\/span><\/p>\n

    MEDIA CONTACT:
    \n<\/b>
    Kate Coyle
    \n
    +1 302-633-7490
    \n
    kate.coyle@agilent.com<\/a><\/p>\n

    KEYWORDS:<\/b> United States North America California<\/p>\n

    INDUSTRY KEYWORDS:<\/b> Research Technology Medical Devices FDA Health Technology Software Pharmaceutical Health Science Oncology<\/p>\n

    MEDIA:<\/b><\/p>\n\n\n\n\n
    Logo<\/b><\/font><\/td>\n<\/tr>\n
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    Agilent Receives FDA Approval for PD-L1 IHC 22C3 pharmDx in Esophageal or Gastroesophageal Junction (GEJ) Carcinoma Test enables identification of patients whose tumors express PD-L1 for potential treatment with KEYTRUDA\u00ae (pembrolizumab)1, 2 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 PD-L1 IHC 22C3 pharmDx, Code SK006, as a companion diagnostic to aid in identifying patients with esophageal or gastroesophageal junction (GEJ) carcinoma who may be eligible for treatment with KEYTRUDA\u00ae (pembrolizumab), Merck\u2019s anti-PD-1 therapy. PD-L1 IHC 22C3 pharmDx, Code SK006, is the only FDA-approved companion diagnostic indicated to identify patients with esophageal or GEJ carcinoma whose tumors express PD-L1 (Combined Positive Score (CPS) \u2265 1) who may … <\/p>\n

    Continue reading “Agilent Receives FDA Approval for PD-L1 IHC 22C3 pharmDx in Esophageal or Gastroesophageal Junction (GEJ) Carcinoma”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-946922","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nAgilent Receives FDA Approval for PD-L1 IHC 22C3 pharmDx in Esophageal or Gastroesophageal Junction (GEJ) Carcinoma - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/agilent-receives-fda-approval-for-pd-l1-ihc-22c3-pharmdx-in-esophageal-or-gastroesophageal-junction-gej-carcinoma\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Agilent Receives FDA Approval for PD-L1 IHC 22C3 pharmDx in Esophageal or Gastroesophageal Junction (GEJ) Carcinoma - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Agilent Receives FDA Approval for PD-L1 IHC 22C3 pharmDx in Esophageal or Gastroesophageal Junction (GEJ) Carcinoma Test enables identification of patients whose tumors express PD-L1 for potential treatment with KEYTRUDA\u00ae (pembrolizumab)1, 2 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 PD-L1 IHC 22C3 pharmDx, Code SK006, as a companion diagnostic to aid in identifying patients with esophageal or gastroesophageal junction (GEJ) carcinoma who may be eligible for treatment with KEYTRUDA\u00ae (pembrolizumab), Merck\u2019s anti-PD-1 therapy. 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(NYSE: A)today announced that it has received U.S. Food and Drug Administration (FDA) approval for PD-L1 IHC 22C3 pharmDx, Code SK006, as a companion diagnostic to aid in identifying patients with esophageal or gastroesophageal junction (GEJ) carcinoma who may be eligible for treatment with KEYTRUDA\u00ae (pembrolizumab), Merck\u2019s anti-PD-1 therapy. PD-L1 IHC 22C3 pharmDx, Code SK006, is the only FDA-approved companion diagnostic indicated to identify patients with esophageal or GEJ carcinoma whose tumors express PD-L1 (Combined Positive Score (CPS) \u2265 1) who may … Continue reading \"Agilent Receives FDA Approval for PD-L1 IHC 22C3 pharmDx in Esophageal or Gastroesophageal Junction (GEJ) Carcinoma\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/agilent-receives-fda-approval-for-pd-l1-ihc-22c3-pharmdx-in-esophageal-or-gastroesophageal-junction-gej-carcinoma\/","og_site_name":"Market Newsdesk","article_published_time":"2026-03-26T14:00:34+00:00","og_image":[{"url":"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&sty=20260326909115r1&sid=flmnd&distro=nx&lang=en","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"3 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/agilent-receives-fda-approval-for-pd-l1-ihc-22c3-pharmdx-in-esophageal-or-gastroesophageal-junction-gej-carcinoma\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/agilent-receives-fda-approval-for-pd-l1-ihc-22c3-pharmdx-in-esophageal-or-gastroesophageal-junction-gej-carcinoma\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Agilent Receives FDA Approval for PD-L1 IHC 22C3 pharmDx in Esophageal or Gastroesophageal Junction (GEJ) Carcinoma","datePublished":"2026-03-26T14:00:34+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/agilent-receives-fda-approval-for-pd-l1-ihc-22c3-pharmdx-in-esophageal-or-gastroesophageal-junction-gej-carcinoma\/"},"wordCount":600,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/agilent-receives-fda-approval-for-pd-l1-ihc-22c3-pharmdx-in-esophageal-or-gastroesophageal-junction-gej-carcinoma\/#primaryimage"},"thumbnailUrl":"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&sty=20260326909115r1&sid=flmnd&distro=nx&lang=en","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/agilent-receives-fda-approval-for-pd-l1-ihc-22c3-pharmdx-in-esophageal-or-gastroesophageal-junction-gej-carcinoma\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/agilent-receives-fda-approval-for-pd-l1-ihc-22c3-pharmdx-in-esophageal-or-gastroesophageal-junction-gej-carcinoma\/","name":"Agilent Receives FDA Approval for PD-L1 IHC 22C3 pharmDx in Esophageal or Gastroesophageal Junction (GEJ) Carcinoma - 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