Geneoscopy, a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, has announced that the US Food and Drug Administration (FDA) approved its non-invasive colorectal cancer (CRC) screening test, ColoSense.
ColoSense is indicated as a screening test for adults, 45 years of age or older, who are at typical average risk for developing CRC.
Designated as a Breakthrough Device by the FDA, ColoSense is the first non-invasive 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.
“Securing FDA approval for ColoSense marks a significant milestone for Geneoscopy and demonstrates that our patented RNA technology can provide millions of eligible adults with a safe and effective option for detecting CRC and advanced adenomas,” said Andrew Barnell, CEO and co-founder of Geneoscopy. “This achievement is a testament to our deep dedication and commitment to bringing innovative technology to market that will improve outcomes for this deadly, yet preventable, disease.”
Geneoscopy’s CRC-PREVENT trial evaluated participants aged 45 and older from various racial, ethnic and socioeconomic backgrounds. Using a novel decentralised enrolment approach, 64% of participants had never been screened for colorectal cancer, and 68% of participants had not scheduled a colonoscopy at the time of enrolment. This is unlike traditional centralised trials, in which patients are typically already engaged in healthcare screening programmes. 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. Additionally, ColoSense detected 45% of advanced adenomas, when the disease is most preventable.
FDA approval of ColoSense is a significant step in making this important screening tool available to patients. Geneoscopy is working with payors, professional societies, and advocacy partners to support a commercial launch later this year or early in 2025 to ensure patients have timely access to ColoSense to support CRC screening. Geneoscopy will launch ColoSense in collaboration with Labcorp, a global leader of innovative and comprehensive laboratory services.
