FDA approves ColoSense - a noninvasive multi-target stool RNA (mt-sRNA) colorectal cancer screening test

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 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.

“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.”

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.

Geneoscopy’s CRC-PREVENT trial evaluated participants aged 45 and older from various racial, ethnic, and socioeconomic backgrounds. Using a novel decentralized enrollment approach, 64% of participants had never been screened for colorectal cancer, and 68% of participants had not scheduled a colonoscopy at the time of enrollment. This is unlike traditional centralized trials, in which patients are typically already engaged in healthcare screening programs. 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. Notably, the study reported 100% CRC sensitivity and 44% AA sensitivity in patients aged 45-49, a critically important screening demographic.