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  • Accuracy, Sensitivity, and Specificity | Cologuard Plus™ and Cologuard . . .
    The Cologuard Plus™ test has a 95% CRC sensitivity and a 94% specificity (adjusted to average-risk patients aged 45-75 years) so no conclusions can be drawn about which is more effective In their respective clinical trials, both tests were shown to effectively detect CRC in comparison to FIT 1,2 † Cologuard Plus specificity:
  • New England Journal of Medicine Publishes Cologuard Plus Test Results . . .
    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%
  • The BLUE-C Study (Cologuard Plus) Guidelines+ Trials Spotlight
    Notably, the test exhibited a 30% reduction in the false-positive rate compared to the DeeP-C trial, the pivotal FDA study for the original Cologuard test Furthermore, Cologuard Plus achieved a 94% sensitivity for detecting colorectal cancer, with a specificity of 91% for non-advanced findings and 93% for no findings
  • FDA Approves Cologuard Plus for Adults at Average Risk for CRC
    The trial also demonstrated that the sensitivity of Cologuard Plus and 7510 participants had negative colonoscopy results Cologuard Plus shows 91% specificity when Jun 5th 2025 - Jul 12th
  • Next-Generation Cologuard Surpasses FIT for Colorectal Cancer Detection . . .
    The multitarget next-generation stool DNA test Cologuard Plus demonstrated sensitivity of 94% for colorectal cancer (CRC) at a specificity of 91% for advanced neoplasia in a cohort of 20 000 adults aged 40 years and older at average risk who were undergoing routine screening colonoscopy 1 The findings, from the BLUE-C study, were published in the New England Journal of Medicine 2 on March 14
  • Next-Generation Cologuard® Test Demonstrates High Sensitivity and . . .
    The Cologuard test is not a replacement for colonoscopy in high-risk patients The Cologuard test performance in adults ages 45-49 is estimated based on a large clinical study of patients 50 and
  • How Accurate is Cologuard? 2025 Study Results Revealed
    Detailed Look at Sensitivity and Specificity Rates To break it down further: Sensitivity: Measures how well the test detects those with the disease For Cologuard, this number is relatively high Specificity: Measures how well the test identifies those without the disease Cologuard’s specificity is around 87%, meaning it may not always be
  • Study deeming colon cancer screening device effective published
    US-based Exact Sciences Corp said that results from the study, published in The New England Journal of Medicine, detail how the use of its Cologuard Plus device saw 94% sensitivity for CRC at 91% specificity Go deeper with GlobalData Reports GlobalData is the parent company of Clinical Trials Arena
  • Exact Sciences Launches the Cologuard™ Plus Test, Transforming . . .
    The Cologuard Plus test demonstrated 95% sensitivity for colorectal cancer detection at 94% specificity, making it the most accurate noninvasive CRC screening test reported in studies to dateMadison, Wis , March 31, 2025 — Exact Sciences Corp (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, today announced the
  • Exact Sciences Launches the Cologuard Plus Test, Transforming . . .
    The Cologuard Plus test demonstrated 95% sensitivity for colorectal cancer detection at 94% specificity, making it the most accurate noninvasive CRC screening test reported in studies to date Greater Confidence in Negative Results: A negative Cologuard Plus result means a 99 98% chance the patient does not have colorectal cancer—offering
  • FDA Approves Cologuard Plus, Next-Gen Noninvasive Colorectal Cancer . . .
    The company anticipates launching Cologuard Plus with Medicare coverage and guideline inclusion in 2025, the statement said The agency’s decision was based on findings from the pivotal multicenter prospective BLUE-C study in which, among a subset of 20 176 evaluable adults undergoing screening colonoscopy, Cologuard Plus showed an overall sensitivity for CRC of 93 9%, a specificity for
  • Next-Gen Cologuard Test Demonstrates High Sensitivity, Specificity
    Exact Sciences Corp , a provider of cancer screening and diagnostic tests, announced positive top-line results from the BLUE-C study The results show that next-generation Cologuard met all study endpoints and improved every top-line metric, including a 30% lower false positive rate, when compared to DeeP-C, the FDA registrational trial for Cologuard





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