The U.S. Food and Drug Administration (FDA) on October 4 approved the Cologuard Plus multitarget stool DNA test for colorectal cancer (CRC) screening among adults with average risk of CRC.

Agency approval was based on findings from the pivotal BLUE-C study. Among nearly 19,000 average-risk participants, the Cologuard Plus test demonstrated 95% overall cancer sensitivity and 43% sensitivity for advanced precancerous lesions at 94% specificity with no findings on colonoscopy. Results from BLUE-C also show the Cologuard Plus test significantly outperformed an independent fecal immunochemical test (FIT) for overall CRC sensitivity, treatable-stage CRC (stages I-III) sensitivity, high-grade dysplasia sensitivity, and advanced precancerous lesion sensitivity.

The original Cologuard test, which has been used more than 17 million times, looks for certain DNA markers and blood in the stool that are associated with colorectal cancer and precancer and was shown in the pivotal DeeP-C study to effectively detect colorectal cancer and precancer. The Cologuard test is noninvasive, can be completed at home, and does not require special preparation.

Upon launch in 2025, the Cologuard Plus test is anticipated to be covered by Medicare, included in the U.S. Preventive Services Taskforce guidelines, and included within quality measures.

Reference:

FDA approves Exact Sciences' Cologuard Plus ^TM test, setting a new benchmark in non-invasive colorectal cancer screening. Press release. Exact Sciences; October 4, 2024. Accessed October 7, 2024. https://www.exactsciences.com/newsroom/press-releases/fda-approves-exact-sciences-cologuard-plus-test