ColoSense is recommended as a first-line test for colorectal cancer screening, with a three-year screening interval
Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, announced that its ColoSense test has been included in the National Comprehensive Cancer Network Guidelines for Colorectal Cancer (CRC) Screening as a first-line test for average-risk patients, supporting its role as a screening alternative for individuals aged 45 years and older. ColoSense is a noninvasive stool-based test for detecting CRC and advanced adenomas, and is the only FDA-approved screening test utilizing stool RNA biomarkers, which are not subject to age-related methylation.
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The NCCN Guidelines are comprehensive, evidence-based recommendations to support the prevention, diagnosis, and treatment of more than 97% of cancers affecting patients in the United States. They are regularly updated to reflect the latest scientific evidence and improve the quality and consistency of cancer care.
“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 Erica Barnell, M.D., Ph.D., Chief Science and Medical Officer of Geneoscopy. “As the first and only FDA-approved stool RNA screening test for colorectal cancer, this affirms the scientific rigor behind our technology and reinforces the importance of noninvasive modalities in expanding access and improving screening compliance, especially among populations less likely to undergo colonoscopy.”
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ColoSense’s inclusion in the NCCN Guidelines is based on data from Geneoscopy’s CRC-PREVENT pivotal study, which was published in the Journal of the American Medical Association. Unlike traditional centralized trials, in which patients are typically already engaged in healthcare screening programs, nearly two-thirds of CRC-PREVENT participants had never undergone CRC screening or scheduled a colonoscopy at the time of enrollment. The study demonstrated ColoSense’s ability to detect CRC with 94% sensitivity, identifying 100% of CRC in Stage I. Additionally, ColoSense detected 46% of advanced adenomas, when the disease is most preventable.
“The NCCN Guidelines heavily impact both the clinical adoption and insurance coverage of screening tests,” said Matt Sargent, Chief Commercial Officer of Geneoscopy. “Achieving this milestone as a first-line test marks a pivotal step forward in our mission to bring ColoSense to market as an accurate, accessible screening solution for millions of Americans. NCCN guideline inclusion also positions ColoSense for future inclusion in other major guidelines.”
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Source – businesswire
