Geneoscopy announced that the U.S. Food and Drug Administration (FDA) has approved ColoSense, the firm's noninvasive multitarget stool RNA colorectal cancer (CRC) screening test.
ColoSense is indicated as an at-home screening test for adults ages 45 and older who are at average risk for developing CRC. The test, which uses RNA biomarkers, received a breakthrough device designation from the FDA in 2021.
In a statement, Geneoscopy noted that RNA biomarkers are not subject to age-related methylation patterns that can lead to variability in test performance across different age groups. The firm noted that ColoSense is the first noninvasive CRC screening test to use RNA biomarkers for a dynamic view of disease activity.
Geneoscopy submitted its premarket approval application for the test in January 2023 based on results from the CRC-PREVENT trial. The trial evaluated participants ages 45 and older from varied racial, ethnic, and socioeconomic backgrounds -- 64% of whom had never been screened for CRC, and 68% of whom had not scheduled a colonoscopy at the time of enrollment.
ColoSense demonstrated 93% sensitivity for detecting CRC in average-risk participants and 45% sensitivity for detecting advanced adenomas. Moreover, ColoSense demonstrated 100% sensitivity for detecting CRC and 44% sensitivity for advanced adenoma detection in the 1,800 (20% of the total) average-risk participants between the ages of 45 and 49, a significant finding for the prevention of early-onset CRC.
Geneoscopy said that it is currently working with payers, professional societies, and advocacy partners to support a commercial launch later this year or early in 2025 in collaboration with Labcorp.
