Labcorp Announces FDA Approval of Companion Diagnostic Supporting Patients with Advanced Melanoma

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    "url": "https://www.prnewswire.com/news-releases/labcorp-announces-fda-approval-of-companion-diagnostic-supporting-patients-with-advanced-melanoma-302846587.html",
    "title": "Labcorp Announces FDA Approval of Companion Diagnostic Supporting Patients with Advanced Melanoma",
    "excerpt": "BURLINGTON, N.C. , Aug. 10, 2026 /PRNewswire/ -- Labcorp (NYSE: LH ), a global leader of innovative and comprehensive laboratory services, today announced that the U.S. Food and Drug Administration (FDA) has approved Labcorp's PGDx elio® tissue complete CDx as a companion diagnostic to help identify patients with advanced melanoma with certain BRAF variants who may benefit from treatment with FDA-approved targeted therapies i . Addressing a Critical Need in Advanced Melanoma Melanoma is the deadliest form of skin cancer, with a five‑year survival rate of just 16% for patients diagnosed with stage IV disease. However, targeted therapies are an important treatment option for patients with advanced melanoma whose tumors have a BRAF alteration. As a companion diagnostic, PGDx elio tissue complete CDx helps clinicians identify which melanoma patients carry these BRAF V600E/K variants and may benefit from treatment with FDA-approved BRAF inhibitors and BRAF/MEK inhibitor combination regimens. \"Advanced melanoma is an extremely aggressive and life‑threatening cancer, but targeted treatments are offering real hope for patients,\" said Shakti Ramkissoon, M.D., Ph.D., vice president, medical lead for oncology at Labcorp. \"Labcorp's FDA‑approved companion diagnostic improves access to these therapies by allowing clinicians to confirm which patients may be eligible for and can start...",
    "product": "PGDx elio tissue complete CDx",
    "summary": "Labcorp's PGDx elio® tissue complete CDx received FDA approval as a companion diagnostic to identify advanced melanoma patients who may benefit from certain targeted therapies.",
    "location": "Burlington, North Carolina, USA",
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    "published_at": "2026-08-10T11:00:00Z",
    "location_data": [
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        "city": "Burlington",
        "state": "North Carolina",
        "region": "Northern America",
        "country": "United States",
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    "effective_date": "2026-08-10",
    "article_sentence": "Labcorp (NYSE: LH ), a global leader of innovative and comprehensive laboratory services, today announced that the U.S. Food and Drug Administration (FDA) has approved Labcorp's PGDx elio® tissue complete CDx as a companion diagnostic to help identify patients with advanced melanoma with certain BRAF variants who may benefit from treatment with FDA-approved targeted therapies i ."
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