FDA approves Cologuard Plus, Exact Sciences’ next generation stool test for CRC screening
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The FDA approved Exact Sciences’ Cologuard Plus multitarget stool DNA test to screen adults aged 45 years or older at average risk for colorectal cancer, according to a company press release.
Compared with the original Cologuard test approved by the FDA in 2014, the company’s next-generation test uses “novel biomarkers and improved laboratory processes,” the release stated. Further, the stool DNA test allows patients to have ample time to return their samples to laboratories boosting the rate of receiving valid results.
“To meaningfully improve outcomes in colorectal cancer, we must catch cancer early when it is most treatable – and find advanced precancers, which can prevent cases of this cancer,” Thomas F. Imperiale, MD, professor of medicine at the Indiana University School of Medicine and research scientist at the Regenstrief Institute, said in the release. “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. This makes the Cologuard Plus test a strong option for first-line screening of average risk patients.”
The agency based its decision on data from the multicenter, prospective BLUE-C trial, which compared the efficacy of the Cologuard Plus stool DNA test with an independent fecal immunological test and colonoscopy in more than 20,000 adults aged 40 years old and older.
According to BLUE-C results, Cologuard Plus showed sensitivities of 95% and 43% for CRC and advanced precancerous lesions, respectively, at 94% specificity without findings on colonoscopy. Further, the test “significantly outperformed” FIT for CRC sensitivity overall, CRC stages one to three, high-grade dysplasia and advanced precancerous lesions, the release stated.
“Cologuard Plus sets a new performance standard in non-invasive colorectal cancer screening for patients,” Kevin Conroy, chairman and CEO of Exact Sciences, said. “Cologuard Plus detects cancers and precancerous polyps with even greater sensitivity than Cologuard while reducing false positives by more than 30%t. This breakthrough comes at a critical time, when 60 million Americans are not up to date with screening.”
The company noted the Cologuard Plus test is expected to launch in 2025 with coverage under Medicare and inclusion in USPSTF guidelines.
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