Next-generation Cologuard demonstrates improved colorectal cancer sensitivity, specificity
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Next-generation Cologuard exhibited improved colorectal cancer specificity and sensitivity compared with results of the FDA registrational trial that led to approval of the noninvasive screening test, its manufacturer reported.
Using colonoscopy as a reference method, the prospective multicenter BLUE-C study compared the performance of multiple colorectal cancer screening tests, including Cologuard — a multitarget stool DNA test developed by Exact Sciences in partnership with Mayo Clinic — and a fecal immunochemical test.
The study — which included more than 20,000 adults aged 40 years or older — met all endpoints, demonstrating improved cancer sensitivity and specificity, as well as improved precancer specificity, according to an Exact Sciences-issued press release.
BLUE-C results showed improved performance with next-generation Cologuard in every metric compared with the performance observed in DeeP-C, the FDA registrational trial for Cologuard. The improved outcomes included greater specificity including nonadvanced findings (91% vs. 87%), specificity including no findings (93% vs. 90%), cancer sensitivity (94% vs. 92%), high-grade dysplasia sensitivity (75% vs. 69%) and advanced precancer sensitivity (43% vs. 42%).
"Accurate and early detection of colorectal cancer and precancerous lesions is critical for reducing incidence and preventing deaths from this disease," Thomas F. Imperiale, MD, professor of medicine at Indiana University School of Medicine, research scientist at Regenstrief Institute and principal investigator for BLUE-C, said in the press release. “The results from this large study of a representative population provide affirmation that Exact Sciences continues at the forefront of noninvasive screening. These new results suggest improved performance of [a multitarget stool DNA] test, strengthening the case for molecular stool-based testing."
Exact Sciences intends to complete an FDA submission for next-generation Cologuard by the end of this year, according to the press release.
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