St. Louis– Geneoscopy has announced that its RNA-based stool test, ColoSense®, has been included in the latest National Comprehensive Cancer Network® (NCCN) Guidelines as a first-line option for colorectal cancer (CRC) screening. The update positions ColoSense as a recommended noninvasive screening method for average-risk individuals aged 45 and older, with a suggested screening interval of every three years.
ColoSense is the first and only FDA-approved colorectal cancer screening test that uses stool RNA biomarkers, offering an alternative to DNA-based tests or colonoscopy. The RNA approach is not affected by age-related methylation, allowing for consistent performance across diverse age groups.
The NCCN Guidelines are widely regarded as one of the most authoritative resources in oncology, shaping clinical practice and insurance coverage policies across the U.S. Their inclusion of ColoSense reflects growing confidence in noninvasive diagnostics and the test’s robust performance in detecting early-stage cancer.
“The NCCN Guidelines are among the most trusted clinical resources in oncology, and the addition of ColoSense is a powerful validation of its clinical performance,” said Dr. Erica Barnell, Chief Science and Medical Officer at Geneoscopy. “This reinforces the importance of noninvasive options in broadening access and improving compliance, particularly for populations that are less likely to undergo colonoscopy.”
The guideline update follows data from Geneoscopy’s pivotal CRC-PREVENT study, published in JAMA. The study showed that ColoSense detected colorectal cancer with 94% sensitivity, including 100% of Stage I cancers. It also identified 46% of advanced adenomas, a critical window for preventing cancer development. Notably, the trial population included a majority of individuals who had never been screened for CRC or scheduled a colonoscopy, underscoring the test’s value in reaching underserved patients.
“Being named a first-line option in the NCCN Guidelines is a transformative milestone,” said Matt Sargent, Chief Commercial Officer at Geneoscopy. “It will accelerate clinical adoption and support broader insurance coverage, helping us deliver ColoSense to millions of Americans who need accessible and accurate screening.”
The inclusion of ColoSense in the NCCN Guidelines paves the way for its potential adoption into additional major medical guidelines and expands its role in advancing early detection efforts for colorectal cancer.
