Next-Generation Colorectal Cancer Screening Test Enables Earlier Disease Detection

By LabMedica International staff writers
Posted on 15 Dec 2023

Image: The multi-target stool RNA (mt-sRNA) biomarker panel is designed to detect precancerous lesions and cancer (Photo courtesy of Geneoscopy)

Colorectal cancer (CRC) stands as the second leading cause of cancer-related deaths in the U.S. and is particularly prevalent in men under 50. Notably, there's been a shift in CRC affecting younger individuals, with 20% of cases in 2019 occurring in people 54 and younger, a rise from 11% in 1995. Additionally, there has been an increase in advanced disease incidence, particularly in individuals under 65. A significant number of CRC cases and deaths can be prevented through regular screening, surveillance, and quality treatment. Now, a new technology offers convenient at-home test collection with the highest sensitivity available for non-invasive CRC screening.

Geneoscopy Inc. (St. Louis, MO, USA) has developed a multi-target stool RNA (mt-sRNA) biomarker panel for detecting precancerous lesions and colorectal cancer. RNA, a dynamic molecule crucial for protein synthesis, adapts to disease conditions and regulates numerous genes in cellular processes. Changes in RNA pathways are linked to the onset and advancement of various cancers. Geneoscopy's RNA-focused method utilizes the seRNA signal from epithelial cells shed in the gastrointestinal tract, ensuring comprehensive tissue sampling near lesions. RNA-based biomarkers, which offer an amplified signal across multiple transcripts in a pathway, could surpass DNA-based biomarkers in effectiveness.

By examining the downstream effects of precancerous mutations, this RNA transcriptome analysis enables precise detection across all pathways of cancer development. Geneoscopy has submitted a Premarket Approval Application (PMA) to the FDA, based on positive results from the pivotal CRC-PREVENT trial. In this study, Geneoscopy's test exhibited high sensitivity for detecting CRC and advanced adenomas. Remarkably, the test showed 100% sensitivity for CRC in younger participants aged 45 to 49. These results are unparalleled for any noninvasive CRC screening test in any prospective registrational clinical study to date.

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Geneoscopy Inc.