Ten years after first collecting an FDA approval, it’s time for version number two. Exact Sciences has received an agency green light for Cologuard Plus, the next generation of its mainstay, at-home screening test for colorectal cancer.
Compared to the original Cologuard, the addition of newly identified genetic biomarkers to the multi-target stool DNA test has reduced its rate of false positives by 30%, while maintaining similar sensitivity rates both in spotting tumors and advanced precancerous polyps.
According to the company, this will also bring a reduction in the number of unnecessary follow-up colonoscopies. The test is designed for people at an average risk for colorectal cancer, including those without a family history of the disease or a previous diagnosis that would potentially increase their chances.
Cologuard Plus, which was developed through a collaboration with the Mayo Clinic, has also improved its ability to stabilize the quality of a sample, giving the user more time to return their kit to Exact Sciences’ laboratory.
Clinical results from a head-to-head trial of 20,000 participants, comparing the new test to fecal immunochemical testing, was published earlier this year in the New England Journal of Medicine. The BLUE-C study pegged the test’s sensitivity for detecting early, stage I disease at 87%, compared to a FIT average of 50%.
That number rose to 94% for stage II, 97% for stage III, and 100% for stage IV and cases that could not be classified. It also demonstrated a combined specificity of 96% among adults ages 45 to 54.
“Cologuard Plus sets a new performance standard in non-invasive colorectal cancer screening for patients,” CEO Kevin Conroy said in a statement. “This breakthrough comes at a critical time when 60 million Americans are not up to date with screening.”
Exact Sciences said the original Cologuard test has been used more than 17 million times since obtaining a nod from the FDA in August 2014. The company plans to deliver Cologuard Plus through the same commercial platform, spanning more than 350 health systems, after it launches in 2025.