The Oatmeal Bite

The Oatmeal Bite

FDA Approves 2nd Blood CRC Test

Freenome's SimpleScreen CRC cleared FDA on July 27 with 81.1% cancer sensitivity and 90.4% specificity - but the approval only solves half the problem when 45 million Americans still won't show up for a colonoscopy follow-up.

Jonathan Govette, CEO/Oatmeal's avatar
Jonathan Govette, CEO/Oatmeal
Aug 04, 2026
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Colorectal cancer will kill more than 55,000 Americans this year. Ninety percent of those deaths are preventable. And roughly 45 to 48 million eligible adults are currently overdue for screening - a number that climbs toward 60 million when you add those due for rescreening.

On July 27, 2026, the FDA approved SimpleScreen CRC, Freenome's blood-based screening test for colorectal cancer in adults 45 and older at average risk. Abbott will exclusively commercialize it in the U.S. this fall. This is the second blood-based primary CRC screening test approved by the FDA, joining Guardant Health's Shield, which was approved in 2024.

The test is a genuine breakthrough. A simple blood draw. No bowel prep. No sedation. No need to arrange transportation home. But the approval is only half the equation. The other half - what happens when the test returns a positive result - is where most health systems and FQHCs are not ready.

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