FDA Approves New Non-Invasive Colorectal Cancer Screening Test
Cologuard Plus is approved for adults aged 45 years and older who are at average risk for the disease.
The FDA has approved Cologuard Plus to detect colorectal cancer in adults aged 45 years and older who are at average risk for the disease, Exact Sciences announced in a release.1 The company said it expects to launch the multitarget stool DNA test with Medicare coverage and guideline inclusion in 2025.
FDA Approves New Non-Invasive Colorectal Cancer Screening Test / Dr_Microbe - stoc.adobe.com
The approval of Cologuard Plus was based on data from the BLUE-C study (NCT04144738), in which the test demonstrated a higher sensitivity to colorectal cancer than an independent fecal immunochemical test. The trial is one of the largest prospective, head-to-head studies ever conducted in colorectal cancer screening. Results were published in The New England Journal of Medicine.2
“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, a principal investigator on the BLUE-C study, said in a release.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. This makes the Cologuard Plus test a strong option for first-line screening of average risk patients.”
BLUE-C is a multi-center, prospective study evaluating the sensitivity and specificity of Cologuard Plus for colorectal cancer in asymptomatic patients aged 40 years or older. The study cohort includes over 20000 patients who completed the Cologuard Plus and an independent fecal immunochemical test. The primary study outcomes were sensitivity of the test for colorectal cancer and specificity for advanced neoplasia.
Of the participants, 98 had colorectal cancer, 2144 had advanced precancerous lesions, 6973 had nonadvanced adenomas, and 10,961 had nonneoplastic findings or negative colonoscopy. Cologuard Plus demonstrated 95% overall cancer sensitivity and 43% sensitivity for advanced precancerous lesions at 94% specificity with no findings on colonoscopy.
Cologuard Plus also significantly outperformed the independent fecal immunochemical test for overall colorectal cancer sensitivity, treatable-stage sensitivity, high-grade dysplasia sensitivity, and advanced precancerous lesion sensitivity. However, it had lower specificity for advanced neoplasia compared to the independent fecal immunochemical test. There were no adverse events associated with Cologuard Plus during the study.
“Cologuard Plus sets a new performance standard in non-invasive colorectal cancer screening for patients,” Kevin Conroy, chairman and CEO of Exact Sciences, said in a release.1 “Cologuard Plus detects cancers and precancerous polyps with even greater sensitivity than Cologuard while reducing false positives by more than 30 percent. This breakthrough comes at a critical time, when 60 million Americans are not up to date with screening.”
Colorectal cancer is the second most common cause of cancer in the United States. According to data from the CDC, over 50000 people died from colorectal cancer in 2022. The disease has a 64% overall 5-year survival rate. However, that number jumps to 88.5% when the cancer is caught before it spreads to other parts of the body. This is why screening tests are critical for early detection.3
READ MORE: Oncology Resource Center
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