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# FDA OKs Breakthrough Colorectal Cancer Test
- URL: https://www.fdaweb.com/fda-oks-breakthrough-colorectal-cancer-test/
- Published: 2024-05-07T12:00:00.000Z
- Updated: 2026-09-14T14:30:13.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5156934

FDA has approved a Geneoscopy PMA for its colorectal cancer stool-based screening test ColoSense, indicated for adults aged 45 years and older who are at typical average risk for developing colorectal cancer (CRC). Designated as a breakthrough device earlier by FDA, the company says )the test is the “first noninvasive colorectal cancer screening test to provide a dynamic view of disease activity by using RNA biomarkers. RNA biomarkers are not subject to age-related methylation patterns that can lead to variability in test performance across different age groups.”

Approval was based on data from the CRC-PREVENT trial that evaluated participants aged 45 and older from various racial, ethnic, and socioeconomic backgrounds, according to the company. “In average-risk individuals, ColoSense successfully demonstrated 93% sensitivity for CRC and importantly identified 100% of CRC in Stage I, when the disease is most curable,” it says. “Additionally, ColoSense detected 45% of advanced adenomas, when the disease is most preventable.”

Colorectal cancer is the second deadliest cancer in the U.S., Geneoscopy notes. A positive ColoSense result may indicate the presence of colorectal cancer, advanced adenomas, or serrated precancerous lesions and should be followed by a colonoscopy, it says.