{"id":935880,"date":"2026-02-11T06:55:46","date_gmt":"2026-02-11T11:55:46","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/agilent-receives-fda-approval-for-pd-l1-ihc-22c3-pharmdx-in-epithelial-ovarian-fallopian-tube-or-primary-peritoneal-carcinoma-eoc\/"},"modified":"2026-02-11T06:55:46","modified_gmt":"2026-02-11T11:55:46","slug":"agilent-receives-fda-approval-for-pd-l1-ihc-22c3-pharmdx-in-epithelial-ovarian-fallopian-tube-or-primary-peritoneal-carcinoma-eoc","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/agilent-receives-fda-approval-for-pd-l1-ihc-22c3-pharmdx-in-epithelial-ovarian-fallopian-tube-or-primary-peritoneal-carcinoma-eoc\/","title":{"rendered":"Agilent Receives FDA Approval for PD-L1 IHC 22C3 pharmDx in Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma (EOC)"},"content":{"rendered":"

<\/p>\n

Agilent Receives FDA Approval for PD-L1 IHC 22C3 pharmDx in Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma (EOC)<\/b><\/p>\n

\nApproval expands first-line PD-L1 testing to support treatment decisions with KEYTRUDA\u00ae (pembrolizumab)1, 2<\/sup><\/p>\n

SANTA CLARA, Calif.–(BUSINESS WIRE<\/a>)–Agilent Technologies Inc.<\/a> (NYSE: A) today announced that the U.S. Food and Drug Administration (FDA) has approved PD-L1 IHC 22C3 pharmDx, Code SK006, as the only FDA-approved companion diagnostic indicated to aid in identifying first-line patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma (EOC), whose tumors express PD-L1 and 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, enables pathologists to assess PD-L1 expression at the time of diagnosis, supporting informed treatment decisions in a disease where therapeutic options remain limited for many patients. This approval marks the seventh FDA approved companion diagnostic indication currently available for PD-L1 IHC 22C3 pharmDx, Code SK006, for use with KEYTRUDA.<\/p>\n

\nNina Green, vice president and general manager of Agilent\u2019s Clinical Diagnostics Division, stated: \u201cDelivering effective precision oncology requires close collaboration between diagnostics and therapeutics, and this FDA approval reflects Agilent\u2019s long-standing industry partnership in companion diagnostics. We are proud to enable pathologists to identify patients with EOC who may benefit from immunotherapy in the first-line setting. As the first immuno-oncology approval for this disease, this milestone underscores our commitment to advancing precision medicine and expanding access to innovative cancer treatments worldwide.\u201d<\/p>\n

\nPD-L1 expression in EOC was evaluated using PD-L1 IHC 22C3 pharmDx, Code SK006, in the KEYNOTE-B96 clinical trial supporting its use in identifying patients who may benefit from KEYTRUDA in the first-line setting.<\/p>\n

\nIn the U.S., ovarian cancer caused approximately 12,730 deaths in 2025 and has a 5-year survival rate of 51.6% between 2015 to 20213<\/sup>.<\/p>\n

\nIn addition to EOC, PD-L1 IHC 22C3 pharmDx, Code SK006, is indicated in the U.S. 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), and gastric or gastroesophageal junction (GEJ) adenocarcinoma who may benefit from treatment with KEYTRUDA.<\/p>\n

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

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

\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\/ovary.html<\/a>, accessed 8 January 2026.<\/p>\n<\/li>\n<\/ol>\n

    \n\u00a0<\/p>\n

    \"\"<\/p>\n

    View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20260210235592\/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 Women FDA Clinical Trials Health Consumer Pharmaceutical Science Oncology<\/p>\n

    MEDIA:<\/b><\/p>\n\n\n\n\n
    Logo<\/b><\/font><\/td>\n<\/tr>\n
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    <\/font><\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

    Agilent Receives FDA Approval for PD-L1 IHC 22C3 pharmDx in Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma (EOC) Approval expands first-line PD-L1 testing to support treatment decisions with KEYTRUDA\u00ae (pembrolizumab)1, 2 SANTA CLARA, Calif.–(BUSINESS WIRE)–Agilent Technologies Inc. (NYSE: A) today announced that the U.S. Food and Drug Administration (FDA) has approved PD-L1 IHC 22C3 pharmDx, Code SK006, as the only FDA-approved companion diagnostic indicated to aid in identifying first-line patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma (EOC), whose tumors express PD-L1 and who may be eligible for treatment with KEYTRUDA\u00ae (pembrolizumab), Merck\u2019s anti-PD-1 therapy. PD-L1 IHC 22C3 pharmDx, Code SK006, enables pathologists to assess PD-L1 expression at the time of diagnosis, supporting informed treatment decisions in … <\/p>\n

    Continue reading “Agilent Receives FDA Approval for PD-L1 IHC 22C3 pharmDx in Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma (EOC)”<\/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-935880","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nAgilent Receives FDA Approval for PD-L1 IHC 22C3 pharmDx in Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma (EOC) - 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-epithelial-ovarian-fallopian-tube-or-primary-peritoneal-carcinoma-eoc\/\" \/>\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 Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma (EOC) - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Agilent Receives FDA Approval for PD-L1 IHC 22C3 pharmDx in Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma (EOC) Approval expands first-line PD-L1 testing to support treatment decisions with KEYTRUDA\u00ae (pembrolizumab)1, 2 SANTA CLARA, Calif.–(BUSINESS WIRE)–Agilent Technologies Inc. (NYSE: A) today announced that the U.S. Food and Drug Administration (FDA) has approved PD-L1 IHC 22C3 pharmDx, Code SK006, as the only FDA-approved companion diagnostic indicated to aid in identifying first-line patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma (EOC), whose tumors express PD-L1 and 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 the U.S. Food and Drug Administration (FDA) has approved PD-L1 IHC 22C3 pharmDx, Code SK006, as the only FDA-approved companion diagnostic indicated to aid in identifying first-line patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma (EOC), whose tumors express PD-L1 and who may be eligible for treatment with KEYTRUDA\u00ae (pembrolizumab), Merck\u2019s anti-PD-1 therapy. PD-L1 IHC 22C3 pharmDx, Code SK006, enables pathologists to assess PD-L1 expression at the time of diagnosis, supporting informed treatment decisions in … Continue reading \"Agilent Receives FDA Approval for PD-L1 IHC 22C3 pharmDx in Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma (EOC)\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/agilent-receives-fda-approval-for-pd-l1-ihc-22c3-pharmdx-in-epithelial-ovarian-fallopian-tube-or-primary-peritoneal-carcinoma-eoc\/","og_site_name":"Market Newsdesk","article_published_time":"2026-02-11T11:55:46+00:00","og_image":[{"url":"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&sty=20260210235592r1&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-epithelial-ovarian-fallopian-tube-or-primary-peritoneal-carcinoma-eoc\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/agilent-receives-fda-approval-for-pd-l1-ihc-22c3-pharmdx-in-epithelial-ovarian-fallopian-tube-or-primary-peritoneal-carcinoma-eoc\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Agilent Receives FDA Approval for PD-L1 IHC 22C3 pharmDx in Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma (EOC)","datePublished":"2026-02-11T11:55:46+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/agilent-receives-fda-approval-for-pd-l1-ihc-22c3-pharmdx-in-epithelial-ovarian-fallopian-tube-or-primary-peritoneal-carcinoma-eoc\/"},"wordCount":597,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/agilent-receives-fda-approval-for-pd-l1-ihc-22c3-pharmdx-in-epithelial-ovarian-fallopian-tube-or-primary-peritoneal-carcinoma-eoc\/#primaryimage"},"thumbnailUrl":"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&sty=20260210235592r1&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-epithelial-ovarian-fallopian-tube-or-primary-peritoneal-carcinoma-eoc\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/agilent-receives-fda-approval-for-pd-l1-ihc-22c3-pharmdx-in-epithelial-ovarian-fallopian-tube-or-primary-peritoneal-carcinoma-eoc\/","name":"Agilent Receives FDA Approval for PD-L1 IHC 22C3 pharmDx in Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma (EOC) - 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