ColoSense – P230001
This is a brief overview of information related to the FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for the FDA’s approval.
Product Name: ColoSense
PMA Applicant: Geneoscopy, Inc.
Address: 2220 Welsch Industrial Court, St. Louis, MO 63146
Approval Date: May 03, 2024
Approval Letter: Approval Order
What is it?
ColoSense is a laboratory test that measures ribonucleic acid (RNA) and hemoglobin (blood) in human stool that is not visible to the eye (fecal occult blood). The ColoSense Collection Kit consists of a container for collection of stool and a separate sampler for collection of stool for hemoglobin testing (only one stool is required to obtain both samples). Both samples are required to obtain a ColoSense result. Additionally, bowel prep or following dietary or medication restrictions to complete the test is not necessary.
A person collects a stool sample at home and sends the sample to a qualified laboratory for processing and testing. In the laboratory, the stool sample is analyzed for the presence of eight RNA biomarkers (molecules that are signs of a normal or abnormal process, condition, or disease) and hemoglobin, which may indicate the presence of colorectal cancer or of advanced adenomas (growths on the lining of the colon or rectum). Based on the combined results of the selected RNA biomarkers, hemoglobin, and smoking status, a positive or negative result is determined. ColoSense results are sent to health care providers for further review.
The ColoSense test is available by prescription for people who are 45 years or older who have an average risk for colorectal cancer.
The results of a ColoSense test, in combination with other clinical information, may be used by a health care provider to determine if a person may have colorectal cancer or advanced adenomas. Advanced adenomas, if left untreated, may develop into cancer. Health care providers should refer people with a positive test result for a colonoscopy. Negative ColoSense test results do not guarantee absence of cancer or advanced adenoma. Health care providers should advise people with a negative test result to continue participating in a colorectal cancer screening program.
ColoSense should not be used to screen people who are under 45 years of age or at higher risk for colorectal cancer. People at higher risk for colorectal cancer include those who:
- Have a history of colorectal cancer, adenomas, or other related cancers.
- Have had a positive result from another colorectal cancer screening method within the last six months.
- Have been diagnosed with a condition that places them at higher risk for colorectal cancer.
- Have been diagnosed with a relevant cancer syndrome passed on from their family.