Labcorp Launches FDA-Approved PTEN Companion Diagnostic for Prostate Cancer

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  "detected_at": "2026-08-04T11:00:00+00:00",
  "company": {
    "name": "Labcorp",
    "domain": "labcorp.com"
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    "url": "https://www.prnewswire.com/news-releases/labcorp-launches-fda-approved-pten-companion-diagnostic-for-prostate-cancer-302841950.html",
    "title": "Labcorp Launches FDA-Approved PTEN Companion Diagnostic for Prostate Cancer",
    "excerpt": "First FDA-approved IHC assay identifies patients who may be eligible for combination treatment with TRUQAP® (capivasertib) BURLINGTON, N.C. , Aug. 4, 2026 /PRNewswire/ -- Labcorp (NYSE: LH ), a global leader of innovative and comprehensive laboratory services, announced the nationwide availability of Roche's VENTANA® PTEN (SP218) RxDx Assay , the first immunohistochemistry (IHC) companion diagnostic test approved by the U.S. Food and Drug Administration (FDA) to determine PTEN protein loss, also known as PTEN deficiency, in tumors of patients with prostate adenocarcinoma. The assay helps identify patients who may be eligible for treatment with AstraZeneca's TRUQAP ® (capivasertib) in combination with abiraterone acetate and prednisone. Addressing an Unmet Need in Prostate Cancer Care Excluding skin cancer, prostate cancer is the most common cancer among men in the United States, with more than 330,000 new cases expected each year. PTEN is a tumor suppressor protein that plays a critical role in regulating cell growth. Loss of PTEN protein expression has been associated with more aggressive disease progression and reduced benefit from current standard-of-care therapies in prostate cancer. Until recently, there were no approved treatment options specifically targeting this biology. The VENTANA PTEN (SP218) RxDx Assay is a companion diagnostic designed to detect PTEN protein loss...",
    "product": "VENTANA PTEN (SP218) RxDx Assay",
    "summary": "Labcorp has launched nationwide availability of Roche's VENTANA PTEN (SP218) RxDx Assay, the first FDA-approved immunohistochemistry (IHC) companion diagnostic test for identifying PTEN protein loss in prostate cancer patients.",
    "location": "United States",
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    "confidence": 0.95,
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      "name": "VENTANA PTEN (SP218) RxDx Assay",
      "full_text": "Roche's VENTANA® PTEN (SP218) RxDx Assay , the first immunohistochemistry (IHC) companion diagnostic test approved by the U.S. Food and Drug Administration (FDA) to determine PTEN protein loss",
      "fuzzy_match": false,
      "release_type": "assay"
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    "product_tags": [
      "medical",
      "general_technology"
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    "published_at": "2026-08-04T11:00:00Z",
    "location_data": [
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        "region": "Northern America",
        "country": "United States",
        "continent": "Americas",
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    "effective_date": "2026-08-04",
    "article_sentence": "Labcorp (NYSE: LH ), a global leader of innovative and comprehensive laboratory services, announced the nationwide availability of Roche's VENTANA® PTEN (SP218) RxDx Assay , the first immunohistochemistry (IHC) companion diagnostic test approved by the U.S. Food and Drug Administration (FDA) to determine PTEN protein loss, also known as PTEN deficiency, in tumors of patients with prostate adenocarcinoma.",
    "related_company_name": "Roche",
    "related_company_domain": "roche.com"
  }
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