Exact Sciences plans to submit next-generation Cologuard tests for FDA approval, the company announced recently.
According to a release, the results from its BLUE-C study saw 94 percent sensitivity for colorectal cancer at 91 percent specificity compared to 92 percent and 87 percent, respectively, for Cologuard’s DeeP-C trial in 2014.
“Cologuard is a groundbreaking innovation in non-invasive cancer detection,” Exact Sciences CEO Kevin Conroy said in a statement. “Next-generation Cologuard will set a new performance standard. 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.”
The BLUE-C study included more than 20,000 adults, 40 years of age or older. Developed in partnership with the Mayo Clinic, next-generation Cologuard features novel biomarkers and improved laboratory processes.
The biotech company plans to complete its application to the FDA in the coming months.