Cologuard Plus Receives FDA Approval For Non-Invasive Colorectal Cancer Screening
The new screening test provides an easier, convenient option for patients seeking to screen themselves for colorectal cancer.
Today, the FDA approved the Cologuard Plus test, a multitarget stool DNA test that can screen adults ages 45 and older who are at average risk for colorectal cancer, according to a news release from Exact Sciences.1
Approval was based on positive results from the BLUE-C trial (NCT04144738), which found that the test showed 93.9% sensitivity for colorectal cancer and 43.4% sensitivity for advanced precancerous lesions. There was 90.6% specificity for advanced neoplasia.2,3
In the label population, which was around 19,000 individuals at average risk of colorectal cancer, Cologuard Plus demonstrated 95% overall cancer sensitivity, in addition to 43% sensitivity for advanced precancerous lesions at 94% specificity.1
Importantly, those results also indicate that Cologuard Plus demonstrated significant superiority over an independent fecal immunochemical test (FIT) for overall colorectal cancer sensitivity, treatable-stage colorectal cancer sensitivity, and advanced precancerous lesion sensitivity.2
Thomas F Imperiale, MD, principal investigator for the BLUE-C study, spoke to the need to find advanced precancers to improve outcomes in patients with colorectal cancer.1
“The high colorectal cancer sensitivity and specificity of the Cologuard Plus test gives me confidence in the test’s ability to do just that while simultaneously maintaining a low risk of false positives,” he said in the news release. “This makes the Cologuard Plus test a strong option for first-line screening of average risk patients.”1
New, less invasive colorectal cancer screening options are increasingly hitting the market as data show their effectiveness. Earlier this year, the FDA approved a novel blood test from Guardant Health which can screen for colorectal cancer in adults ages 45 and older at average disease risk.4
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