Positive top-line results from the pivotal BLUE-C study showed that the next-generation Cologuard met all study endpoints and improved every top-line metric, including a 30% lower false positive rate compared to DeeP-C, the FDA registrational trial for Cologuard.
The American Cancer Society’s recent report on the increasing incidence rates of colorectal cancer in young adults once again rang an alarm bell for adults over 45 to get checked, especially if they are having symptoms. But as an oncologist with more than 40 years of experience, I also believe that this should be a clarion call to scientists and researchers, and for regulators at the FDA.
