Geneoscopy has enrolled the first patients in the CRC-PREVENT pivotal trial to evaluate the safety and efficacy of Geneoscopy's noninvasive, at-home diagnostic screening test to successfully detect colorectal neoplasms, including advanced adenomas, in average-risk individuals, a group with no known co-morbidities associated with cancer risk and therefore more challenging to diagnose. The company's innovative diagnostic was granted Breakthrough Device Designation by the FDA in January of 2020.
"We are pleased to initiate this important study and validate the use of Geneoscopy's RNA-FIT assay as a valuable noninvasive tool to help prevent cancer through routine colorectal cancer screening," commented Dr Erica Barnell, Geneoscopy's co-founder and Chief Scientific Officer. "The ultimate goal of colorectal screening is cancer prevention, but this requires diagnostic screening options with the sensitivity to identify clinically relevant pre-cancerous lesions, including advanced adenomas. The RNA-FIT assay aims to deliver the necessary sensitivity and specificity in a simple, at-home collection kit."
The prospective, single-arm study will enrol more than 12,000 patients across the US. Patients will submit samples via the mail and subsequently undergo optical colonoscopy examination. All significant lesions discovered during colonoscopy will be biopsied or removed and sent for histopathology. A comparative analysis will be conducted to determine sensitivities and specificities, as applicable, for colorectal cancer, advanced adenomas, non-advanced adenomas, benign hyperplastic polyps, and colonoscopies without findings.
"When it comes to detecting advanced adenomas, noninvasive tests are not currently hitting a 50% threshold. Until now, only colonoscopy can detect advanced adenomas reliably," commented Dr David Lieberman, Professor of Medicine, Division of Gastroenterology and Hepatology at the Oregon Health Sciences University School of Medicine. "A noninvasive, at-home option that successfully detects these pre-cancerous lesions would represent an important, positive step in early detection for colorectal cancer prevention."
Geneoscopy's initial clinical study demonstrated high sensitivity of its multifactor RNA-FIT assay compared with colonoscopy findings, demonstrating 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 promising data was previously presented by Barnell, at the Association for Molecular Pathology (AMP) 2020 Annual Meeting and the peer-reviewed article recently published in Clinical and Translational Gastroenterology.