Next Generation Cologuard Test Demonstrates 94 Percent Sensitivity for Colorectal Cancer at 91 Percent specificity, Raising the Bar in Non-invasive Screening

BLUE-C study met all endpoints, showing improved cancer sensitivity, specificity, and precancer sensitivity

20,000-participant study reflects racial and ethnic diversity of the U.S.

Company plans to complete FDA submission for next-generation Cologuard by end of 2023


MADISON, Wis., June 20, 2023 – Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, today announced positive top-line results from the pivotal BLUE-C study. 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.


Cologuard in
Deep-C study1
Next-gen Cologuard
in BLUE-C study2

including non-advanced findings

 87 91

including no findings

90 93
Cancer sensitivity 92 94
High-grade dysplasia sensitivity 69 75
Advanced precancer sensitivity 42 43

Note: specificity including non-advanced findings includes colonoscopy results that were negative for cancer or advanced precancer upon histopathological review; specificity including no findings includes no findings on colonoscopy and no histopathological review; high-grade dysplasia includes carcinoma in situ and stage 0 cancer

“Cologuard is a groundbreaking innovation in non-invasive cancer detection. Next-generation Cologuard will set a new performance standard,” said Kevin Conroy, chairman and CEO of Exact Sciences. “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."*3,4

Topics: Exact Sciences News, Investor Relations

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