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Evaluation of Colorectal Cancer Risk and Prevalence by Stool DNA Integrity Detection
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Multitarget stool DNA testing for colorectal-cancer screening.

Thomas F Imperiale1, David F Ransohoff, Steven H Itzkowitz

  • 1From the Department of Medicine, Indiana University School of Medicine, the Regenstrief Institute, the Simon Cancer Center, and the Center for Innovation at Roudebush Veterans Affairs Medical Center - all in Indianapolis (T.F.I.); the Departments of Medicine and Epidemiology and the Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill (D.F.R.); the Dr. Henry D. Janowitz Division of Gastroenterology, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York (S.H.I.); Kaiser Permanente Medical Center, Walnut Creek, CA (T.R.L.); Boston Biostatistics Research Foundation, Framingham MA (P.L.); Exact Sciences, Madison, WI (G.P.L., B.M.B.); and the Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN (D.A.A.).

The New England Journal of Medicine
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A new multitarget stool DNA test shows higher sensitivity for detecting colorectal cancer and precancerous lesions compared to the fecal immunochemical test (FIT). While more effective, the DNA test also yielded a higher false positive rate than FIT.

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Area of Science:

  • Oncology
  • Gastroenterology
  • Molecular Diagnostics

Background:

  • Colorectal cancer (CRC) screening is crucial for early detection and improved patient outcomes.
  • Noninvasive screening methods offer a potential advantage for increasing screening participation.
  • Accurate and effective noninvasive tests are needed to enhance CRC screening programs.

Purpose of the Study:

  • To compare the performance of a novel multitarget stool DNA test against the fecal immunochemical test (FIT) for colorectal cancer screening.
  • To evaluate the sensitivity and specificity of both noninvasive tests in detecting colorectal cancer and advanced precancerous lesions.
  • To assess the diagnostic accuracy of stool DNA testing in asymptomatic individuals at average risk for CRC.

Main Methods:

  • A comparative study involving asymptomatic individuals at average risk for colorectal cancer.
  • Utilized a multitarget stool DNA test analyzing KRAS mutations, NDRG4 and BMP3 methylation, and β-actin, alongside a hemoglobin immunoassay.
  • Compared results with a standard fecal immunochemical test (FIT), with both tests processed independently of colonoscopic findings.

Main Results:

  • The stool DNA test demonstrated significantly higher sensitivity for detecting colorectal cancer (92.3% vs. 73.8%) and advanced precancerous lesions (42.4% vs. 23.8%) compared to FIT.
  • DNA testing showed improved detection rates for polyps with high-grade dysplasia and large serrated sessile polyps.
  • FIT exhibited higher specificity (94.9%) compared to the DNA test (86.6%) among participants with negative findings.

Conclusions:

  • Multitarget stool DNA testing is more sensitive than FIT for detecting colorectal cancer and advanced precancerous lesions in average-risk individuals.
  • The stool DNA test resulted in a higher number of false positives compared to FIT.
  • Despite a higher false positive rate, the stool DNA test's enhanced detection capabilities warrant consideration for CRC screening strategies.