In a unanimous 10-0 decision, the FDA’s molecular and clinical genetics panel approved Exact Sciences’ noninvasive, stool-based colon cancer test, known as Cologuard, putting it on track toward potential market approval. After a recent study of 13,000 subjects showed that Cologuard detected 92% of cancers and 42% of advanced precancerous lesions, The New England Journal of Medicine published an online report last week claiming the test, which requires patients to submit a stool sample, was found to detect early-stage cancer better than other noninvasive approaches.
If Cologuard were approved, patients receiving positive results from the test would be asked to undergo a colonoscopy.
The panel’s vote indicates that it believes the benefits of the test outweigh the risks. The FDA does not need to follow the advice of the panel, but it often does. Meanwhile, Exact Sciences agreed to evaluate Cologuard’s performance over time through another study of 1,830 people in 20 locations.
