Abbott has launched SimpleScreen CRC, an FDA-approved blood-based colorectal cancer screening test developed and manufactured by Freenome. The test is intended for average-risk adults age 45 and older, particularly those who decline or do not complete preferred stool-based or visual screening options.
In the PREEMPT CRC study of more than 48,000 asymptomatic adults, SimpleScreen CRC demonstrated 81.1% sensitivity for colorectal cancer, including 63.5% for Stage I disease, 13.7% sensitivity for advanced precancerous lesions, and 90.4% specificity for advanced colorectal neoplasia. The test uses circulating cell-free DNA (cfDNA) from a blood sample.
Abbott says SimpleScreen CRC is covered by Medicare, with no out-of-pocket costs for eligible Medicare Part B patients. The company is also offering patient navigation, including blood-draw coordination, reminders, insurance assistance and follow-up support.
Importantly, a positive result requires follow-up colonoscopy to complete the screening process.