Freenome Wins FDA Clearance for Colorectal Cancer Blood Test in Adults 45 and Older
Updated
Updated · The Independent · Aug 3
Freenome Wins FDA Clearance for Colorectal Cancer Blood Test in Adults 45 and Older
3 articles · Updated · The Independent · Aug 3
Summary
SimpleScreen is the second FDA-approved blood test for colorectal cancer screening, targeting average-risk adults 45 and older and returning results within a couple of weeks after a doctor’s office blood draw.
More than 48,000 adults were studied, with Freenome saying the test detected about 8 in 10 colorectal cancers and correctly ruled out disease or advanced precancerous lesions in 9 in 10 people.
A positive result still requires a follow-up colonoscopy, underscoring that the test is meant to widen screening access rather than replace existing diagnostic procedures.
Abbott plans to help launch the test this fall, though pricing has not been disclosed; the only other FDA-cleared rival, Guardant Health’s Shield, was approved in 2024.
The approval lands as U.S. colorectal cancer cases rise, with nearly 109,000 new colon cancer cases and close to 50,000 rectal cancer cases expected this year.