Abbott’s Cologuard Plus® Receives CE Mark for Colorectal Cancer Screening in Europe

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  "signal_type": "news",
  "signal_subtype": "achieves_certification",
  "detected_at": "2026-10-21T11:00:00+00:00",
  "company": {
    "name": "Abbott",
    "domain": "abbott.com"
  },
  "data": {
    "url": "https://www.prnewswire.com/news-releases/abbotts-cologuard-plus-erhalt-die-ce-kennzeichnung-fur-die-darmkrebsvorsorge-in-europa-302915369.html",
    "title": "Abbott’s Cologuard Plus® Receives CE Mark for Colorectal Cancer Screening in Europe",
    "excerpt": "ABBOTT PARK, Ill., Oct. 21, 2026 /PRNewswire/ -- Abbott, a global healthcare leader, announced today that the Cologuard Plus® test has received CE Mark certification under the European Union's In Vitro Diagnostic Regulation (IVDR). This is an important step in making the non-invasive colorectal cancer screening test available in Europe. Cologuard Plus is a DNA test designed to detect both colorectal cancer and advanced precancerous lesions. The test analyzes DNA markers and blood in stool associated with colorectal cancer and precancerous lesions and requires no bowel preparation, dietary restrictions, or sedation. The CE mark represents a key regulatory milestone in Abbott's plans to make Cologuard Plus accessible to people in Europe. Abbott plans to launch the test in select European markets, with timing and availability varying by country depending on local care pathways, reimbursement, and operational readiness. \"Screening is one of the most effective tools we have in the fight against colorectal cancer, but it only works if people actually do it,\" said Jake Orville, senior vice president of Abbott's molecular diagnostics business. \"Cologuard helped revolutionize colorectal cancer screening in the United States by giving people an effective and convenient option they can do at home. With Cologuard Plus, we have built on that experience and increased performance even...",
    "summary": "Abbott announced that its Cologuard Plus test has received CE Mark certification under the European Union's In Vitro Diagnostic Regulation.",
    "location": "Abbott Park, Illinois, United States",
    "planning": false,
    "image_url": "https://mma.prnewswire.com/media/2761216/Abbott_New_Logo.jpg?p=facebook",
    "confidence": 0.95,
    "recognition": "CE Mark certification under the European Union's In Vitro Diagnostic Regulation (IVDR)",
    "published_at": "2026-10-21T11:00:00Z",
    "location_data": [
      {
        "city": "Abbott Park",
        "state": "Illinois",
        "region": "Northern America",
        "country": "United States",
        "continent": "Americas",
        "fuzzy_match": false
      }
    ],
    "effective_date": "2026-10-21",
    "article_sentence": "Abbott, a global healthcare leader, announced today that the Cologuard Plus® test has received CE Mark certification under the European Union's In Vitro Diagnostic Regulation (IVDR)."
  }
}

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