FDA Approves Multitarget Stool DNA Test for Patients at Average Risk for Colorectal Cancer

On October 4, 2024, the US Food and Drug Administration (FDA) approved the Cologuard Plus™test, a next-generation multitarget stool DNA test, for patients 45 years and older at average risk for colorectal cancer (CRC). This approval was based on results from the BLUE-C study. 

In this prospective, head-to-head study, researchers collected stool specimens from 20176 asymptomatic patients 40 years and older with CRC (n = 98), advanced precancerous lesions (n = 2144), non-advanced adenomas (n = 6973), and non-neoplastic findings or negative colonoscopy results (n = 10961) who were scheduled or planning to undergo a screening colonoscopy. Specimens were analyzed prior to colonoscopy preparation using Cologuard Plus^TM and a commercially available fecal immunochemical test. The primary end point was testing sensitivity and specificity for patients with advanced neoplasia. Key secondary end points included quantification of sensitivity for patients with advanced precancerous lesions, specificity for patients with non-neoplastic findings or negative colonoscopy, and comparison of sensitivities for patients with CRC and advanced precancerous lesions.

At analysis, with Cologuard Plus^TM sensitivity for patients with CRC was 93.9% and specificity for patients with advanced neoplasia was 90.6%. Sensitivity for patients with advanced precancerous lesions was 43.4% and specificity for patients with non-neoplastic findings or negative colonoscopy was 92.7%. With a commercially available fecal immunochemical test, sensitivity was 67.3% for patients with CRC and 23.3% for patients with advanced precancerous lesions. Specificity was 94.8% for patients with advanced neoplasia and 95.7% for patients with non-neoplastic findings or negative colonoscopy. Cologuard Plus™ was superior for sensitivity for patients with CRC (P < .001) and for patients with advanced precancerous lesions (P < .001) but led to inferior specificity for patients with advanced neoplasia (P < .001). No adverse events were reported.

“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,” stated study investigator Thomas Imperiale, MD, Indiana University School of Medicine, Indianapolis, Indiana.  “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.” 

Source: 

FDA approves Exact Sciences’ Cologuard Plus™ test, setting a new benchmark in non-invasive colorectal cancer screening. Accessed on October 7, 2024. https://www.exactsciences.com/newsroom/press-releases/fda-approves-exact-sciences-cologuard-plus-test 

Imperiale TF, Porter K, Zella J, et al. Next-generation multitarget stool DNA test for colorectal cancer screening. N Engl J Med. Published online: March 13, 2024. doi: 10.1056/NEJMoa2310336