RNA-Based Noninvasive Gut Tests Enable Early Colorectal Cancer Screening

Disease progression begins with polyps that may develop into cancer over time. Early detection and treatment are crucial to improve survival. Unfortunately, most newly diagnosed patients suffer from advanced disease. Colonoscopy remains the gold standard for CRC screening. Now, a new diagnostic platform uses stool-derived eukaryotic RNA (seRNA) to detect colorectal cancer and precancerous adenomas. The device was awarded Breakthrough Device Designation from the US FDA for its ability to reduce morbidity associated with colorectal cancer through advanced adenoma detection. Preliminary trials suggest that the diagnostic can detect these lesions at a higher rate than all existing noninvasive screening tests.

Unlike other noninvasive screening options that use DNA or blood-based biomarkers, the proprietary method from Geneoscopy Inc. (St. Louis, MO, USA) analyzes RNA extracted from patient stool samples to provide the phenotypic and quantitative information necessary to accurately detect precancerous lesions. There is a significant unmet need within the CRC screening market for a noninvasive means to not only accurately detect cancer at an early stage, but also advanced adenomas - pre-cancerous polyps that are most likely to become cancerous. Early detection is critical as it allows these lesions to be removed and prevents progression to cancer.

RNA provides a real-time snapshot of what is occurring in the body, allowing for accurate interpretation of DNA variants and a better assessment of the patient’s current health status. Human cells are constantly being shed from the gastrointestinal lining and passed in the stool. However, isolation of human RNA from stool is extremely difficult due to extensive bacterial noise and heavy signal degradation. Geneoscopy’s proprietary extraction method eliminates bacterial noise, enriches for host signals, and effectively preserves intact RNA.

"As positive momentum continues to build for our pivotal and ongoing 10,000-patient trial, the team remains focused on ensuring a successful launch of our noninvasive multifactor RNA colorectal cancer screening test as a meaningful advancement in the fight to prevent colorectal cancer," said Andrew Barnell, Geneoscopy's co-founder and CEO. "Moreover, we have already made exciting progress towards broadening our diagnostic portfolio to address additional unmet needs within gastrointestinal health."

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Geneoscopy Inc.