Pharmaceutical Executive October 4, 2024
Don Tracy, Associate Editor

Approval of Cologuard Plus follows results from the BLUE-C study, which demonstrated a 95% sensitivity for detecting colorectal cancer.

The FDA has approved Exact Sciences’ Cologuard Plus, a non-invasive colorectal cancer (CRC) screening test, for adults aged 45 years and older with an average risk for CRC. According to the company, the regulatory action was based on results from the pivotal BLUE-C study, which demonstrated sufficient sensitivity in detecting colorectal cancer and advanced precancerous lesions.1

“To meaningfully improve outcomes in colorectal cancer, we must catch cancer early—when it is most treatable—and find advanced precancers, which can prevent cases of this cancer,” said Thomas F. Imperiale, MD, professor of medicine, Indiana University School of Medicine, research scientist, Regenstrief Institute, principal investigator,...

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Topics: FDA, Govt Agencies, Patient / Consumer, Provider
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