| Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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| Device | ColoSense® |
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| Generic Name | System, Colorectal Neoplasia, RNA Markers and Hemoglobin detection |
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| Applicant | Geneoscopy, Inc.
2220 Welsch Industrial Ct.
St. Louis, MO 63146 |
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| PMA Number | P230001 |
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| Supplement Number | S012 |
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| Date Received | 01/30/2026 |
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| Decision Date | 08/27/2026 |
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| Product Code |
SBB |
| Advisory Committee |
Pathology |
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| Supplement Type | Normal 180 Day Track |
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| Supplement Reason | Change Design/Components/Specifications/Material |
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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
ColoSense is intended for the qualitative detection of colorectal neoplasia associated RNA markers and for the presence of occult hemoglobin in human stool. ColoSense is a single-site test performed at Geneoscopy, Inc. 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 typical average-risk for developing CRC. ColoSense is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals. |
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