Trends in Anesthesiology

Exact Sciences Corp., a leading provider of cancer screening and diagnostic tests, today announced the U.S. Food and Drug Administration (FDA) approved the Cologuard Plus™ test, the company’s next generation multitarget stool DNA test. The Cologuard Plus test is now approved for adults ages 45 and older who are average risk for colorectal cancer (CRC).

FDA approval was based on findings from the pivotal BLUE-C study, one of the largest prospective, head-to-head studies ever conducted in CRC screening. Among the subset of 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.

CRC is often considered the most preventable, yet least prevented form of cancer. It remains the second deadliest cancer in the United States. Upon launch in 2025, the Cologuard Plus test is anticipated to be covered by Medicare, included in the U.S. Preventive Services Taskforce (USPSTF) guidelines, and included within quality measures.

Source: asamonitor.pub/3NhmVVw