Preventive health care just took a massive step forward. On July 27, 2026, the U.S. Food and Drug Administration (FDA) approved SimpleScreen™ CRC, a novel blood-based test designed to screen for colorectal cancer in adults aged 45 and older who are at average risk.
Developed by biotechnology firm Freenome and commercialized nationwide in partnership with Abbott, this new tool allows doctors to check for colorectal cancer through a simple, routine blood sample—no uncomfortable prep drinks or stool collection kits required.
For millions of adults who have put off life-saving screenings due to fear or inconvenience, this approval changes everything.
Colorectal cancer is the second leading cause of cancer-related deaths in the United States, yet it is also one of the most preventable and treatable forms of cancer when caught early.
Despite clear guidelines recommending that adults begin screening at age 45, an estimated 60 million Americans are currently overdue for their screening. The reasons are familiar:
Because the most effective screening test is always the one that actually gets completed, having a quick, non-invasive option integrated directly into routine annual checkups removes the primary barriers holding people back.
When cancer or precancerous cells exist in the body, they shed microscopic fragments of DNA into the bloodstream, known as cell-free DNA (cfDNA).
SimpleScreen™ CRC uses advanced artificial intelligence and machine learning models to analyze subtle molecular patterns—specifically genomic methylation signals—within these blood samples to spot early warning signs of cancer.
The FDA approval was backed by data from the PREEMPT CRC study, the largest clinical trial ever conducted for a blood-based colorectal cancer test, enrolling over 48,000 participants across more than 200 health centers:
SimpleScreen™ CRC is intended for adults aged 45 and older who are at average risk for colorectal cancer and receive a referral from their doctor.
However, it is important to understand where blood testing fits into your overall healthcare plan:
With official FDA clearance complete, Medicare coverage criteria met, and inclusion in the updated American Cancer Society screening guidelines, Abbott is rolling out SimpleScreen™ CRC across clinics and medical labs.
By turning cancer screening into something as straightforward as a routine cholesterol or diabetes blood panel, healthcare providers now have a powerful tool to catch cancer earlier—when it is most treatable—and save countless lives. If you are 45 or older and overdue for your screening, speak with your doctor to see if a simple blood test is right for you.