United States
Choose your country

Select to view the solutions available in your location.

Login
Patient login

Track orders, get results, manage personal information, and more.

Provider login

Order tests, track orders, get results, and more.

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


Topics: Exact Sciences News, Investor Relations

Subscribe To The Blog