Colorectal Cancer: How a New Blood-Based DNA Test Stacks Up in Screening Options

The US FDA recently approved a cell-free DNA (cfDNA) blood-based screening test for colorectal cancer (CRC). The test, Shield (Guardant Health), is the first blood test to be approved as a primary screening option for CRC in line with other noninvasive screening options recommended in screening guidelines, and the first blood test to meet the performance requirements to be covered under Medicare. The approval was based on findings from the multisite ECLIPSE clinical trial, which showed the blood-based DNA test demonstrated 83% sensitivity for the detection of CRC, 90% specificity for advanced neoplasia, and 13% sensitivity for advanced precancerous lesions. How does the Shield test compare to traditional CRC screening methods? William Grady, MD, corresponding author of the ECLIPSE study, discusses in the video above.