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

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