| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | SimpleScreen™ CRC |
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| Generic Name | System, colorectal neoplasia, DNA methylation and hemoglobin detection |
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| Applicant | Freenome, LLC
Bldg. 1
3300 Marina Blvd.
Brisbane, CA 94005 |
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| PMA Number | P250029 |
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| Date Received | 08/01/2025 |
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| Decision Date | 07/24/2026 |
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| Product Code |
PHP |
| Docket Number | 26M-8165 |
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| Notice Date | 07/24/2026 |
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| Advisory Committee |
Molecular Genetics |
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| Clinical Trials | NCT04369053
|
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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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. |
| Approval Order | Approval Order |
|---|
| Summary | Summary of Safety and Effectiveness |
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| Labeling |
Labeling Part 2 |
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| Post-Approval Study | Show Report Schedule and Study Progress |
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| Supplements: |
S001 |
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|
