The FDA has approved Freenome's SimpleScreen CRC, the second blood-based screening test for colorectal cancer in average-risk adults aged 45 and older. While colonoscopies remain the gold standard, approximately 60 million eligible Americans remain unscreened due to preparation and invasiveness barriers. In clinical trials, SimpleScreen CRC detected 81.1% of colorectal cancers by analyzing cell-free DNA and CpG methylation patterns. Medical guidelines recommend blood tests for patients who decline preferred screening methods.
SimpleScreen FDA approval
- ▪Freenome, Inc. partnered with Illinois healthcare company Abbott to commercialize SimpleScreen CRC in the United States
- ▪SimpleScreen CRC is the second blood-based colorectal cancer screening test approved by the FDA, following Guardant Health's Shield test in July 2024
- ▪The FDA approved Freenome, Inc.'s SimpleScreen CRC, a blood-based screening test for colorectal cancer, in July 2026
- ▪SimpleScreen CRC is approved for use in adults aged 45 years and older who are at an average risk of developing colorectal cancer
Colorectal cancer screening barriers
- ▪Colorectal cancer screening barriers include colonoscopy preparation requirements, discomfort, embarrassment, cost concerns, and fear of results
- ▪An estimated 60 million eligible individuals in the United States are currently overdue or do not participate in colorectal cancer screening
Blood test detection accuracy
- ▪SimpleScreen CRC demonstrated a 90.4% specificity rate for detecting advanced colorectal neoplasia in the PREEMPT CRC study
- ▪SimpleScreen CRC detected 52% of Stage I colorectal cancers, whereas Guardant Health's Shield test detected 65% of Stage I cases
- ▪In the PREEMPT CRC study of over 48,000 participants, SimpleScreen CRC detected colorectal cancer with 81.1% sensitivity and advanced precancerous lesions with 13.7% sensitivity
CpG methylation biomarkers
- ▪SimpleScreen CRC specifically detects patterns of cytosine-phosphate-guanine (CpG) methylation, which often occur early in cancer development
- ▪SimpleScreen CRC detects signals associated with colorectal cancer by analyzing cell-free DNA (cfDNA) in the blood
Current screening guidelines
- ▪The American Cancer Society guideline identifies stool-based testing and visual examinations like colonoscopy as preferred screening options
- ▪The American Cancer Society guideline recommends blood-based screening tests for average-risk individuals who decline or do not complete preferred screening options
- ▪A positive result from a blood-based screening test like SimpleScreen CRC requires a follow-up diagnostic colonoscopy to complete the screening process
- ▪The American Gastroenterological Association and the American Society for Gastrointestinal Endoscopy state that blood tests should be reserved for individuals unwilling to undergo colonoscopy or stool-based tests
Patient preference for blood tests
- ▪Recent evidence suggests that many eligible adults would generally prefer blood-based screening tests over colonoscopy or stool-based options
- ▪A real-world study suggests that patient adherence to blood-based colorectal cancer screening could reach 95%
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