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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceSimpleScreen™ CRC
Generic NameSystem, colorectal neoplasia, DNA methylation and hemoglobin detection
ApplicantFreenome, LLC
Bldg. 1
3300 Marina Blvd.
Brisbane, CA 94005
PMA NumberP250029
Date Received08/01/2025
Decision Date07/24/2026
Product Code PHP 
Advisory Committee Molecular Genetics
Clinical TrialsNCT04369053
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
The SimpleScreen™ CRC test is a qualitative, in vitro diagnostic test intended to detect molecular signals associated with colorectal cancer. SimpleScreen CRC utilizes circulating cell-free DNA from plasma of peripheral whole blood collected in the SimpleScreen CRC blood collection kit.SimpleScreen CRC is indicated for colorectal cancer screening in adults aged 45 years and older who are at average risk for the disease. Patients with a positive result should be followed by colonoscopy. SimpleScreen CRC is not a replacement for diagnostic colonoscopy or for surveillance colonoscopy in high-risk individuals.
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