FDA Approves SimpleScreen CRC Blood Test for U.S. Colorectal Cancer Screening
Key Clinical Summary
- The U.S. Food and Drug Administration (FDA) has approved SimpleScreen™ CRC, a blood-based colorectal cancer screening test for adults aged 45 years and older at average risk of colorectal cancer.
- In the PREEMPT CRC prospective validation study of more than 48,000 participants, the test demonstrated 81.1% sensitivity for colorectal cancer and 90.4% specificity for advanced colorectal neoplasia.
- Medicare coverage criteria have been met following FDA approval, and the American Cancer Society is expected to incorporate the test into its screening guidance, potentially expanding access to blood-based colorectal cancer screening.
The U.S. Food and Drug Administration has approved SimpleScreen™ CRC, Freenome's blood-based colorectal cancer screening test, providing a new screening option for average-risk adults aged 45 years and older. Abbott will exclusively commercialize the test in the United States beginning this fall, expanding its colorectal cancer screening portfolio with a blood-based alternative that requires only a routine blood draw.
Study Findings
The approval is based on findings from the PREEMPT CRC study, described as the largest prospective clinical validation study conducted for a blood-based colorectal cancer screening test. The trial enrolled more than 48,000 asymptomatic, average-risk adults aged 45 to 85 years across more than 200 clinical sites, all of whom were scheduled to undergo screening colonoscopy.
In a prespecified analysis adjusted to reflect the U.S. Census population, SimpleScreen CRC detected colorectal cancer with 81.1% sensitivity. The assay detected advanced precancerous lesions (APLs) with 13.7% sensitivity, including 30.7% sensitivity for APLs with high-grade dysplasia. The test demonstrated 90.4% specificity for advanced colorectal neoplasia.
According to Freenome, these results mean the test correctly identified approximately 8 of every 10 colorectal cancers while correctly producing negative results for 9 of every 10 individuals without colorectal cancer or advanced precancerous lesions.
SimpleScreen CRC analyzes cell-free DNA (cfDNA) in blood to detect molecular signals associated with colorectal cancer. Freenome states that the assay incorporates its Personalized Cancer Detection strategy using base-level cfDNA methylation combined with artificial intelligence and machine learning to improve detection accuracy.
Clinical Implications
Colorectal cancer remains the second-leading cause of cancer-related death in the United States, despite being highly preventable and treatable when detected early through recommended screening. Freenome and Abbott estimate that up to 60 million Americans remain overdue for colorectal cancer screening, highlighting the need for additional screening approaches.
The newly approved blood-based test expands available screening options for eligible adults who may not complete stool-based testing or colonoscopy. The test is intended for average-risk adults aged 45 years and older who are referred by a healthcare provider for colorectal cancer screening.
The companies noted that a positive SimpleScreen CRC result requires follow-up diagnostic colonoscopy. The assay is not intended to replace diagnostic colonoscopy or surveillance colonoscopy in individuals at high risk for colorectal cancer.
Following FDA approval, SimpleScreen CRC meets Medicare coverage criteria, and the companies stated that the test is expected to be added by name to American Cancer Society screening guidance, potentially supporting broader adoption.
Reference:
FDA approves Freenome’s SimpleScreen™ CRC blood-based screening test; Abbott to commercialize in the U.S. Press release. Freenome. July 27, 2026. Accessed July 28, 2026.
