Exact Sciences is building on the success of Cologuard® and leveraging 10 years of innovation and experience to develop a new version of Cologuard. Our next-generation Cologuard test is designed to improve performance without losing the simplicity and convenience of an at-home test.
BLUE-C TOP-LINE RESULTS
In June 2023, the company announced top-line results of the multi-center, prospective BLUE-C study, formally named the “Clinical Validation of An Optimized Multi-Target Stool DNA (mt-sDNA 2.0) Test, for Colorectal Cancer Screening Study” (NCT04144738). BLUE-C is one of the largest clinical trials assessing a colorectal cancer screening test, with more than 20,000 adults 40 years of age and older.
The results show that our next-generation
Cologuard® test met all study endpoints1.
|
Next-gen Cologuard in BLUE-C study |
|
| Specificity including non-advanced findings |
91 |
| Specificity
including no findings |
93 |
| Cancer sensitivity | 94 |
| High-grade dysplasia sensitivity | 75 |
| Advanced precancer sensitivity | 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
In the coming months, Exact Sciences plans to release additional analyses of BLUE-C data and complete its application to the FDA for approval of our next-generation Cologuard test.
For additional background information:
- BLUE-C: A Pivotal Clinical Trial
- Press Release: Next-generation Cologuard® Test Demonstrates 94 Percent Sensitivity for Colorectal Cancer at 91 Percent Specificity, Raising the Bar in Non-invasive Screening
- Results Infographic
- Exact Explains: Sensitivity and Specificity
[1] Internal data on file. Exact
Sciences Corporation. Madison, WI.