{"id":823544,"date":"2025-03-10T08:28:55","date_gmt":"2025-03-10T12:28:55","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/agilent-pd-l1-ihc-28-8-pharmdx-receives-eu-ivdr-certification-as-a-companion-diagnostic-test-for-non-small-cell-lung-cancer-and-melanoma-indications\/"},"modified":"2025-03-10T08:28:55","modified_gmt":"2025-03-10T12:28:55","slug":"agilent-pd-l1-ihc-28-8-pharmdx-receives-eu-ivdr-certification-as-a-companion-diagnostic-test-for-non-small-cell-lung-cancer-and-melanoma-indications","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/agilent-pd-l1-ihc-28-8-pharmdx-receives-eu-ivdr-certification-as-a-companion-diagnostic-test-for-non-small-cell-lung-cancer-and-melanoma-indications\/","title":{"rendered":"Agilent PD-L1 IHC 28-8 pharmDx Receives EU IVDR Certification as a Companion Diagnostic Test for Non-small Cell Lung Cancer and Melanoma Indications"},"content":{"rendered":"

<\/p>\n

Agilent PD-L1 IHC 28-8 pharmDx Receives EU IVDR Certification as a Companion Diagnostic Test for Non-small Cell Lung Cancer and Melanoma Indications<\/b><\/p>\n

SANTA CLARA, Calif.–(BUSINESS WIRE<\/a>)–Agilent Technologies Inc.<\/a> (NYSE: A) today announced its PD-L1 IHC 28-8 pharmDx<\/a> kit has received two new companion diagnostic indications approvals under EU IVDR1<\/sup>, expanding the eligibility of treatment to early-stage non-small cell lung cancer (NSCLC) and previously untreated advanced melanoma patients. These two new indications bring the total indications launched in Europe for PD-L1 IHC 28-8 pharmDx to nine. PD-L1 IHC 28-8 pharmDx is approved for exclusive use with the Agilent Autostainer Link 48<\/a> advanced staining solution.\n<\/p>\n

\nLung cancer and malignant melanoma are major healthcare concerns worldwide, with lung cancer accounting for over two million new cases in 2020 and an estimated 1.77 million deaths each year, and malignant melanoma accounting for over 324,000 new cases in 2020 and over 57,000 deaths each year2<\/sup>. PD-L1 is a critical biomarker for potential response to anti-PD-1 therapies, which are revolutionizing the treatment of cancer. Pathology labs play an important role in informing treatment decisions.\n<\/p>\n

\nWhen used in conjunction with the PD-L1 IHC 28-8 pharmDx as a companion test, in the European Union: (a) resectable NSCLC patients with PD-L1 expression \u22651% and at high risk of recurrence may be eligible for treatment with Bristol Myers Squibb\u2019s OPDIVO\u00ae (nivolumab) in combination with platinum based chemotherapy; and (b) patients 12 years of age and older with tumor cell PD-L1 expression < 1% that have previously untreated advanced (metastatic or unresectable) melanoma may be eligible for treatment with Bristol Myers Squibb\u2019s Opdualag\u2122 (nivolumab and relatlimab).\n<\/p>\n

\nPD-L1 IHC 28-8 pharmDx is the only clinically validated test for identifying patients for these treatments; these two new indications will aid pathologists, in conjunction with oncologists, in selecting appropriate treatment options, offering hope for patients diagnosed with these cancers. IVDR compliance certification further enhances the confidence of patients, consumers, and healthcare professionals in the EU by demonstrating that these medical devices can be safely relied upon as part of the diagnostic workflow.\n<\/p>\n

\nSimon May, senior vice president of Agilent\u2019s Life Sciences and Diagnostics Markets Group, remarked: \u201cThe two added indications of PD-L1 IHC 28-8 pharmDx will give physicians in Europe critical information to inform treatment decisions for patients with these common and potentially deadly cancers. This endorsement underscores Agilent\u2019s leadership in the development of companion diagnostics for groundbreaking therapies containing anti-PD-1 antibodies.\u201d\n<\/p>\n

\nAn innovative industry leader with more than 50 years of experience, Agilent launched the first FDA-approved companion diagnostic and continues to deliver world-class CDx products in close collaboration with pharma partners.\n<\/p>\n

\nOPDIVO\u00ae is a registered trademark of Bristol-Myers Squibb Company; Opdualag\u2122 is a trademark of Bristol-Myers Squibb Company.\n<\/p>\n

    \n
  1. \nIn Vitro Diagnostic Medical Devices Regulation (europa.eu)\n<\/li>\n
  2. \nSung. H., Ferlay. J., et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries, CA. Cancer J. Clin. 2021, 71, 209\u2013249\n<\/li>\n<\/ol>\n

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

    \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’ most challenging questions. The company generated revenue of $6.51 billion in fiscal year 2024 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>.\n<\/p>\n

    \"\"<\/p>\n

    View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20250310422488\/en\/<\/a><\/span><\/p>\n

    MEDIA CONTACT
    \n<\/b>
    Naomi Goumillout
    \n
    Agilent Technologies Inc.
    \n
    +1.781.266.2819
    \n
    naomi.goumillout@agilent.com<\/a><\/p>\n

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

    INDUSTRY KEYWORDS:<\/b> Technology Research Software Biotechnology Hardware Health Other Science Science Oncology<\/p>\n

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    Agilent PD-L1 IHC 28-8 pharmDx Receives EU IVDR Certification as a Companion Diagnostic Test for Non-small Cell Lung Cancer and Melanoma Indications SANTA CLARA, Calif.–(BUSINESS WIRE)–Agilent Technologies Inc. (NYSE: A) today announced its PD-L1 IHC 28-8 pharmDx kit has received two new companion diagnostic indications approvals under EU IVDR1, expanding the eligibility of treatment to early-stage non-small cell lung cancer (NSCLC) and previously untreated advanced melanoma patients. These two new indications bring the total indications launched in Europe for PD-L1 IHC 28-8 pharmDx to nine. PD-L1 IHC 28-8 pharmDx is approved for exclusive use with the Agilent Autostainer Link 48 advanced staining solution. Lung cancer and malignant melanoma are major healthcare concerns worldwide, with lung cancer accounting for over two … <\/p>\n

    Continue reading “Agilent PD-L1 IHC 28-8 pharmDx Receives EU IVDR Certification as a Companion Diagnostic Test for Non-small Cell Lung Cancer and Melanoma Indications”<\/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-823544","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nAgilent PD-L1 IHC 28-8 pharmDx Receives EU IVDR Certification as a Companion Diagnostic Test for Non-small Cell Lung Cancer and Melanoma Indications - 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-pd-l1-ihc-28-8-pharmdx-receives-eu-ivdr-certification-as-a-companion-diagnostic-test-for-non-small-cell-lung-cancer-and-melanoma-indications\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Agilent PD-L1 IHC 28-8 pharmDx Receives EU IVDR Certification as a Companion Diagnostic Test for Non-small Cell Lung Cancer and Melanoma Indications - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Agilent PD-L1 IHC 28-8 pharmDx Receives EU IVDR Certification as a Companion Diagnostic Test for Non-small Cell Lung Cancer and Melanoma Indications SANTA CLARA, Calif.–(BUSINESS WIRE)–Agilent Technologies Inc. (NYSE: A) today announced its PD-L1 IHC 28-8 pharmDx kit has received two new companion diagnostic indications approvals under EU IVDR1, expanding the eligibility of treatment to early-stage non-small cell lung cancer (NSCLC) and previously untreated advanced melanoma patients. These two new indications bring the total indications launched in Europe for PD-L1 IHC 28-8 pharmDx to nine. PD-L1 IHC 28-8 pharmDx is approved for exclusive use with the Agilent Autostainer Link 48 advanced staining solution. Lung cancer and malignant melanoma are major healthcare concerns worldwide, with lung cancer accounting for over two … Continue reading "Agilent PD-L1 IHC 28-8 pharmDx Receives EU IVDR Certification as a Companion Diagnostic Test for Non-small Cell Lung Cancer and Melanoma Indications"\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/agilent-pd-l1-ihc-28-8-pharmdx-receives-eu-ivdr-certification-as-a-companion-diagnostic-test-for-non-small-cell-lung-cancer-and-melanoma-indications\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2025-03-10T12:28:55+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&sty=20250310422488r1&sid=flmnd&distro=nx&lang=en\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/agilent-pd-l1-ihc-28-8-pharmdx-receives-eu-ivdr-certification-as-a-companion-diagnostic-test-for-non-small-cell-lung-cancer-and-melanoma-indications\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/agilent-pd-l1-ihc-28-8-pharmdx-receives-eu-ivdr-certification-as-a-companion-diagnostic-test-for-non-small-cell-lung-cancer-and-melanoma-indications\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Agilent PD-L1 IHC 28-8 pharmDx Receives EU IVDR Certification as a Companion Diagnostic Test for Non-small Cell Lung Cancer and Melanoma Indications\",\"datePublished\":\"2025-03-10T12:28:55+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/agilent-pd-l1-ihc-28-8-pharmdx-receives-eu-ivdr-certification-as-a-companion-diagnostic-test-for-non-small-cell-lung-cancer-and-melanoma-indications\\\/\"},\"wordCount\":635,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/agilent-pd-l1-ihc-28-8-pharmdx-receives-eu-ivdr-certification-as-a-companion-diagnostic-test-for-non-small-cell-lung-cancer-and-melanoma-indications\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/cts.businesswire.com\\\/ct\\\/CT?id=bwnews&sty=20250310422488r1&sid=flmnd&distro=nx&lang=en\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/agilent-pd-l1-ihc-28-8-pharmdx-receives-eu-ivdr-certification-as-a-companion-diagnostic-test-for-non-small-cell-lung-cancer-and-melanoma-indications\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/agilent-pd-l1-ihc-28-8-pharmdx-receives-eu-ivdr-certification-as-a-companion-diagnostic-test-for-non-small-cell-lung-cancer-and-melanoma-indications\\\/\",\"name\":\"Agilent PD-L1 IHC 28-8 pharmDx Receives EU IVDR Certification as a Companion Diagnostic Test for Non-small Cell Lung Cancer and Melanoma Indications - 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(NYSE: A) today announced its PD-L1 IHC 28-8 pharmDx kit has received two new companion diagnostic indications approvals under EU IVDR1, expanding the eligibility of treatment to early-stage non-small cell lung cancer (NSCLC) and previously untreated advanced melanoma patients. These two new indications bring the total indications launched in Europe for PD-L1 IHC 28-8 pharmDx to nine. PD-L1 IHC 28-8 pharmDx is approved for exclusive use with the Agilent Autostainer Link 48 advanced staining solution. Lung cancer and malignant melanoma are major healthcare concerns worldwide, with lung cancer accounting for over two … Continue reading \"Agilent PD-L1 IHC 28-8 pharmDx Receives EU IVDR Certification as a Companion Diagnostic Test for Non-small Cell Lung Cancer and Melanoma Indications\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/agilent-pd-l1-ihc-28-8-pharmdx-receives-eu-ivdr-certification-as-a-companion-diagnostic-test-for-non-small-cell-lung-cancer-and-melanoma-indications\/","og_site_name":"Market Newsdesk","article_published_time":"2025-03-10T12:28:55+00:00","og_image":[{"url":"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&sty=20250310422488r1&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-pd-l1-ihc-28-8-pharmdx-receives-eu-ivdr-certification-as-a-companion-diagnostic-test-for-non-small-cell-lung-cancer-and-melanoma-indications\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/agilent-pd-l1-ihc-28-8-pharmdx-receives-eu-ivdr-certification-as-a-companion-diagnostic-test-for-non-small-cell-lung-cancer-and-melanoma-indications\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Agilent PD-L1 IHC 28-8 pharmDx Receives EU IVDR Certification as a Companion Diagnostic Test for Non-small Cell Lung Cancer and Melanoma Indications","datePublished":"2025-03-10T12:28:55+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/agilent-pd-l1-ihc-28-8-pharmdx-receives-eu-ivdr-certification-as-a-companion-diagnostic-test-for-non-small-cell-lung-cancer-and-melanoma-indications\/"},"wordCount":635,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/agilent-pd-l1-ihc-28-8-pharmdx-receives-eu-ivdr-certification-as-a-companion-diagnostic-test-for-non-small-cell-lung-cancer-and-melanoma-indications\/#primaryimage"},"thumbnailUrl":"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&sty=20250310422488r1&sid=flmnd&distro=nx&lang=en","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/agilent-pd-l1-ihc-28-8-pharmdx-receives-eu-ivdr-certification-as-a-companion-diagnostic-test-for-non-small-cell-lung-cancer-and-melanoma-indications\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/agilent-pd-l1-ihc-28-8-pharmdx-receives-eu-ivdr-certification-as-a-companion-diagnostic-test-for-non-small-cell-lung-cancer-and-melanoma-indications\/","name":"Agilent PD-L1 IHC 28-8 pharmDx Receives EU IVDR Certification as a Companion Diagnostic Test for Non-small Cell Lung Cancer and Melanoma Indications - 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