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Next Generation Cologuard

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:


[1] Internal data on file. Exact Sciences Corporation. Madison, WI.