Geneoscopy, an oncology diagnostics firm, recently received approval from the US Food and Drug Administration (FDA) for its groundbreaking noninvasive colorectal cancer (CRC) screening test, ColoSense. This test, designed for individuals aged 45 and older with average risk for CRC, utilizes a unique approach by detecting fecal hemoglobin and RNA biomarkers. Unlike some existing methods, ColoSense is not impacted by age-related methylation, ensuring consistent performance across different age groups.
The approval follows successful trials, including the CRC-PREVENT study, which involved a diverse cohort of participants aged 45 and above. ColoSense exhibited an impressive 93 percent sensitivity for detecting CRC, with a remarkable 100 percent detection rate for stage I tumors. Additionally, it identified 45 percent of advanced adenomas, crucial precursors to CRC, highlighting its potential to enhance patient outcomes by facilitating early detection and intervention.
Of particular significance is ColoSense’s performance in the 45 to 49 age group, where it demonstrated 100 percent sensitivity for CRC and 44 percent sensitivity for advanced adenomas. This age range represents a relatively new segment of the screening-eligible population, potentially offering an appealing alternative to colonoscopy, the current gold standard for CRC screening.
Geneoscopy’s CEO, Andrew Barnell, hailed the FDA approval as a major milestone, emphasizing the significance of their RNA technology in providing a safe and effective screening option for millions of eligible adults. The company, headquartered in St. Louis, plans to launch ColoSense commercially in partnership with the Laboratory Corporation of America later this year or in early 2025.
ColoSense is poised to rival existing stool-based CRC screening tests like Cologuard from Exact Sciences. While Cologuard focuses on DNA mutations, methylation markers, and fecal hemoglobin, ColoSense’s innovative approach offers a compelling alternative, potentially reshaping the landscape of CRC screening with its accuracy, reliability, and accessibility.