Exact Sciences: Next-gen Cologuard Meets All Endpoints In Pivotal BLUE-C Study

(RTTNews) - Exact Sciences Corp. (EXAS), a provider of cancer screening and diagnostic tests with flagship product Cologuard, announced Wednesday positive top-line results from the pivotal BLUE-C study to detect colorectal cancer.

The results show that next-generation Cologuard met all study endpoints and improved every top-line metric, including a 30 percent lower false positive rate, when compared to DeeP-C, the FDA registrational trial for Cologuard. The 20,000-participant trial showed improved cancer sensitivity, specificity, and precancer sensitivity.

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

BLUE-C, a multi-center, prospective study of more than 20,000 adults 40 years of age and older, was designed to evaluate the performance of next-generation Cologuard (multi-target stool DNA or mt-sDNA).

BLUE-C is one of the largest colorectal cancer screening trials ever conducted, the company noted.

The next-generation Cologuard, developed in partnership with Mayo Clinic, features novel biomarkers and improved laboratory processes. Cologuard provides a convenient and accurate testing option for those at average risk.

In the coming months, Exact Sciences said it plans to release additional analyses of the BLUE-C data and complete its application to the FDA for approval of next-generation Cologuard.

Kevin Conroy, chairman and CEO of Exact Sciences, said, "Next-generation Cologuard will set a new performance standard. We are harnessing deep scientific insights, advanced technology, and over a decade of research and development to detect colorectal cancer with greater sensitivity and significantly improve the false positive rate. Once approved, next-generation Cologuard will meaningfully enhance the patient experience, and it comes at a critical time - when there are 60 million unscreened Americans."

In after hours trading on Nasdaq, Exact Sciences stock was gaining around 9.2 percent to trade at $103.05.

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