TEST:

ColoSense™

"Geneoscopy, Inc...received its laboratory permit from the New York State Department of Health. Geneoscopy is now able to provide laboratory services in all 50 states and the District of Columbia. The company’s first commercially available laboratory test will be ColoSense™, an FDA-approved, noninvasive multi-target stool RNA (mt-sRNA) screening test for colorectal cancer (CRC) and advanced adenomas.."

P=N/A, N=14263, Completed, Geneoscopy, Inc. | Active, not recruiting --> Completed | N=8000 --> 14263 | Trial completion date: Sep 2023 --> Jan 2024

There was no significant impact of cross-reactivity from non-colorectal cancer diseases. These data provide a framework for laboratories to complete analytical validation for RNA-based panels that require premarket approval as a class III medical device from the US Food and Drug Administration.