Regenstrief Institute Research Scientist Thomas Imperiale, M.D., served as the principal investigator for Exact Sciences’ BLUE-C study, which led to the recent U.S. Food and Drug Administration (FDA) approval of the Cologuard Plus™ test.
This next-generation, noninvasive colorectal cancer screening test from Exact Sciences is approved for adults 45 and older at average risk for colorectal cancer. The Cologuard Plus test demonstrated high sensitivity in detecting colorectal cancer and advanced precancerous lesions, offering a critical tool for early detection and prevention.
The BLUE-C study, one of the largest prospective studies of its kind, included nearly 19,000 participants. The results showed that the Cologuard Plus test significantly outperformed a fecal immunochemical test (FIT) in terms of cancer sensitivity, particularly in detecting treatable-stage colorectal cancer. Dr. Imperiale emphasized that this new test, with its low false-positive rate, provides a strong option for first-line screening, helping to identify cancer early when it is most treatable.
Thomas F. Imperiale, M.D.
In addition to his role as a research scientist at Regenstrief Institute, Thomas F. Imperiale, M.D., is a core investigator for the U.S. Department of Veterans Affairs Health Services Research and Development Center for Health Information and Communication, Richard L. Roudebush VA Medical Center. He is the Lawrence Lumeng Professor of Gastroenterology and Hepatology at Indiana University School of Medicine.
