ST. LOUIS– Geneoscopy Inc. today announced publication of the peer-reviewed article, “Multitarget Stool RNA Test for Noninvasive Detection of Colorectal Neoplasias in a Multicenter, Prospective, and Retrospective Cohort”, which presents the results of its multifactor RNA-FIT test in Clinical and Translational Gastroenterology. The article reports high sensitivity of the company’s noninvasive, at-home diagnostic screening test to successfully detect colorectal neoplasms, including advanced adenomas, in average-risk individuals within the intended use population for colorectal cancer screening. The promising data was previously presented by Dr. Erica Barnell, Geneoscopy’s co-founder and Chief Scientific Officer, at the Association for Molecular Pathology (AMP) 2020 Annual Meeting.
In comparative analysis versus colonoscopy findings, the RNA-FIT assay demonstrated 95% sensitivity for colorectal cancer, 62% sensitivity for advanced adenomas, and 25% sensitivity for other non-advanced adenomas with an 85% specificity for no findings on a colonoscopy. The prospective study included 1,305 average risk patients and was supplemented with a 22-patient retrospective cohort of patients who were diagnosed with advanced adenomas or colorectal cancer but were sampled prior to treatment or surgical resection. All patients were evaluated with the RNA-FIT assay and an optical colonoscopy.
The RNA-FIT assay was evaluated under a robust study design. Samples were collected from individuals across all 48 contiguous United States and individuals were evaluated at over 600 different endoscopy sites. The study design will be replicated in Geneoscopy’s CRC-PREVENT Clinical Trial, which is currently underway.
“Colorectal cancer can be prevented with early detection of advanced adenomas. Screening compliance is key, and simple, at-home collection kits are emerging as an attractive option. However, it is critical that a diagnostic test has the necessary sensitivity to identify clinically relevant lesions early,” commented Dr. Barnell. “We are pleased to share results of this study and look forward to building upon this body of evidence to support the use of Geneoscopy’s RNA-FIT assay as a valuable noninvasive tool to help prevent cancer through routine colorectal cancer screening.”
Responsible for over 50,000 deaths annually, colorectal cancer (CRC) is the second leading cause of cancer related death in the United States.1 Disease progression begins with polyps that may or may not develop into cancer over time. Early detection and treatment are crucial to improve survival; however, the majority of newly diagnosed patients suffer from advanced disease. Colonoscopy remains the gold-standard for CRC screening in the US, yet this method is frequently met with patient aversion due to its required bowel preparation, sedation, and associated discomfort, which results in low patient compliance. Currently available noninvasive screening methods lack sufficient levels of sensitivity to effectively and reliably detect both early-stage CRC and high-risk precancerous lesions, including advanced adenomas which are a precursor in up to 70% of CRC cases.
The article is currently available online and is scheduled to be published in the May 2021 issue.
