Test Performance
Sensitivity
81.1% for CRC
Specificity
90.4%
Detection Method
cfDNA + protein + methylation
Turnaround
Not yet published (launch fall 2026)
Key Features
Multiomics approach • AI-powered • CRC test in development • Blood-based screening
Who It's For
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.