ColoSense, which had breakthrough device designation by the FDA , detects colorectal neoplasia–associated RNA markers and the presence of occult hemoglobin in human stool.
The FDA approval was based on results of the CRC-PREVENT trial, which evaluated the ColoSense mt-sRNA test in a diverse group of adults undergoing colonoscopy. Among all average-risk individuals, the sensitivity of the mt-sRNA test was 93% for CRC, 100% for early CRC, and 45% for advanced adenomas. In a subgroup of those aged 45-49 years, the sensitivity was 100% for CRC and 44% for advanced adenomas.
Colorectal Cancer (CRC) Cancer Malignant Neoplasia Carcinoma Malignant Neoplasm Colonoscopy Bowel Preparation Preventive Screening Screening Adherence Adherence To Medication Issues For Patients Compliance Drug Compliance Treatment Adherence U.S. Food And Drug Administration United States Food And Drug Administration Fda Hemoglobin Hb Hemoglobin Hgb Hb - Hemoglobin
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