Next-generation Cologuard to be submitted for FDA approval 

Exact Sciences Corp., a leading provider of cancer screening and diagnostic tests, announced in a recent press release positive top-line results from the pivotal BLUE-C study.

The results show that next-generation Cologuard tests 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.

BLUE-C is a multicenter, prospective study of more than 20,000 adults 40 years of age and older. It reflects the racial and ethnic diversity of the U.S.

The company plans to complete FDA submission for next-generation Cologuard tests by the end of 2023.