ColoSense
FDA premarket approval P230001/S005 · decided 2025-05-14
Approval details
- PMA number
- P230001
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ColoSense
- Generic name
- System, Colorectal Neoplasia, RNA Markers and Hemoglobin detection
- Applicant
- Geneoscopy, Inc.
- Date received
- 2024-08-23
- Decision date
- 2025-05-14
- Days to decision
- 264 days
- Decision code
- APPR
- Product code
- SBB
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- St. Louis, MO
- Statement
- ColoSense is a qualitative in vitro diagnostic test intended for the detection of colorectal neoplasia associated RNA markers and for the presence of occult hemoglobin in human stool. A positive ColoSense result may indicate the presence of colorectal cancer (CRC), advanced adenomas (AA) or serrated precancerous lesions (SPL) and should be followed by a colonoscopy. ColoSense is indicated as a screening test for adults, 45 years of age or older, who are at average-risk for developing CRC. ColoSe
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