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     161  0 Kommentare The New England Journal of Medicine Publishes Cologuard Plus Test Results from Pivotal BLUE-C Study

    Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, today announced online publication of the BLUE-C study results in The New England Journal of Medicine. The peer-reviewed study, "Next-Generation Multitarget Stool DNA Test for Colorectal Cancer Screening", will also appear in the journal's March 14, 2024 print issue.

    The 20,000-participant BLUE-C study was designed to determine the performance characteristics of Exact Sciences’ next-generation multitarget stool DNA test, Cologuard Plus, for colorectal cancer (CRC) and to compare that performance to the fecal immunochemical test (FIT), a commonly used noninvasive CRC screening test. Exact Sciences submitted to the U.S. Food and Drug Administration (FDA) its pre-market approval (PMA) application for Cologuard Plus in December 2023, including complete results from BLUE-C, and plans to make the test available in 2025, pending approval.

    Cologuard Plus met all BLUE-C study endpoints, demonstrating 94% sensitivity for CRC at 91% specificity including non-advanced findings, and 93% specificity including no findings. Specificity was even better in younger age groups, at 96% in 45-54 year olds. Cologuard Plus will minimize unnecessary follow-up colonoscopies by reducing the likelihood of a false-positive screening test.

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    Results from BLUE-C also show Cologuard Plus significantly outperformed an independent FIT* for overall CRC sensitivity, treatable-stage CRC (stages I-III) sensitivity, high-grade dysplasia sensitivity, and advanced precancerous lesion sensitivity.

    Cologuard
    Plus1

    Independent
    FIT1

    Cancer sensitivity

    94

    67

    Specificity including non-advanced findings

    91

    95

    Specificity including no findings

    93

    96

    Stages I-III cancer sensitivity

    93

    65

    High-grade dysplasia sensitivity

    75

    47

    Advanced precancer sensitivity

    43

    23

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    The New England Journal of Medicine Publishes Cologuard Plus Test Results from Pivotal BLUE-C Study Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, today announced online publication of the BLUE-C study results in The New England Journal of Medicine. The peer-reviewed study, "Next-Generation …