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 __________________ |
|
| Specificity including non-advanced findings |
87 | 91 |
| Specificity 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
