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Geneoscopy’s Novel Stool-Based RNA Platform Shows High Accuracy in Monitoring Crohn’s Disease

By: via Business Wire

Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, announced the publication of a peer-reviewed study in Gastro Hep Advances, highlighting the effectiveness of Geneoscopy’s noninvasive, stool-based RNA technology platform in managing Crohn’s disease (CD). The data demonstrates the feasibility to leverage stool-based RNA biomarkers to improve disease monitoring within inflammatory bowel disease (IBD).

The study, titled "Noninvasive stool RNA test approximates disease activity in patients with Crohn’s disease," assessed 102 stool samples from 68 individuals, collected over multiple time points before and after the initiation of advanced therapy. The test demonstrated 83% sensitivity and 80% specificity in distinguishing between active disease and remission. Additionally, a secondary classifier successfully differentiated between mild and moderate disease severity among those with active disease, achieving 89% sensitivity and 95% specificity.

“Patients with Crohn’s disease are plagued by unpredictable periods of remission and relapse, necessitating frequent monitoring to assess disease activity and response to therapy,” said Erica Barnell, Chief Medical & Science Officer at Geneoscopy. “Using RNA biomarkers in stool samples to approximate disease activity in CD offers a noninvasive and patient-friendly approach that mitigates the need for physician appointments and uncomfortable procedures like repeated endoscopies. This study demonstrates that Geneoscopy’s technology has the potential to change how we manage and treat CD, enhancing patient outcomes and quality of life.”

CD affects more than 1 million individuals in the U.S.,1 often leading to serious complications and requiring surgery for up to 80% of patients.2 Maintaining long-term remission is crucial to effectively avoid complications, surgery, malignancy, and other side effects.3-5 Despite advancements in treatment options, accurately evaluating disease severity and predicting therapeutic outcomes remain challenging. Geneoscopy’s platform has the potential to deliver more accurate tracking of disease progression, and provide a cost-effective, convenient way to monitor the disease, reducing healthcare expenses and overall burden.

About Geneoscopy, Inc.

Geneoscopy Inc. is a life sciences company focused on developing diagnostic tests for gastrointestinal health. Leveraging its proprietary, patented stool-derived eukaryotic RNA (seRNA) biomarker platform, Geneoscopy’s mission is to empower patients and providers to transform gastrointestinal health through innovative diagnostics. The company’s FDA-approved ColoSense™ test uses a proprietary RNA-based platform to screen for colorectal cancer and advanced adenomas for average-risk individuals over the age of 45. In partnership with leading universities and biopharmaceutical companies, Geneoscopy is also developing diagnostic tests for treatment selection and therapy monitoring in other GI disease areas. For more information, visit www.geneoscopy.com and follow the company on LinkedIn.

References:

  1. Lewis JD, Parlet LE, Funk MLJ, et al. Incidence, Prevalence, and Racial and Ethnic Distribution of Inflammatory Bowel Disease in the United States. Gastroenterol. 2023;165:1197-1205.e2.
  2. Cosnes J, Gower-Rousseau C, Seksik P, Cortot A. Epidemiology and natural history of inflammatory bowel diseases. Gastroenterol. 2011;140(6):1785-1794.
  3. Ashton JJ, Green Z, Kolimarala V, Beattie RM. Inflammatory bowel disease: long-term therapeutic challenges. Expert Rev Gastroenterol Hepatol. 2019;13(11):1049-1063.
  4. Gupta N, Bostrom AG, Kirschner BS, et al. Incidence of stricturing and penetrating complications of Crohn’s disease diagnosed in pediatric patients. Inflamm Bowel Dis. 2010;16(4):638-644.
  5. Dubinsky MC, Lin YC, Dutridge D, et al. Serum immune responses predict rapid disease progression among children with Crohn’s disease: immune responses predict disease progression. Am J Gastroenterol. 2006;101(2):360-367.

 

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