Freenome
Average-risk adults 45+ wanting blood-based colorectal screening
Prices verified Aug 13, 2026 on Freenome's own site
Test Performance
Sensitivity
81.1% for CRC
Specificity
90.4%
Detection Method
cfDNA + protein + methylation
Turnaround
Not yet published (launch fall 2026)
Key Features
FDA approved July 2026 • Blood-based colorectal screening • cfDNA plus protein markers • Medicare coverage approved
Who It's For
Suited to: Average-risk adults 45+ wanting blood-based colorectal screening
Not suited to: People at high risk for whom colonoscopy is recommended
Important Notes
SimpleScreen CRC won FDA approval on 27 July 2026 for average-risk adults 45+: 81.1% CRC sensitivity, 90.4% specificity, 13.7% for advanced precancerous lesions. Blood-based cfDNA with AI/ML, validated in PREEMPT CRC (48,000+ participants). Abbott will exclusively commercialise it in the US from autumn 2026, so pricing is not yet announced. Included in the updated ACS colorectal screening guideline.