TEST:

ColoSense™

"Geneoscopy, Inc..announced the closing of a Series C funding round raising $105 million. Bio-Rad Laboratories (NYSE: BIO and BIO.B) led the financing and was joined by Petrichor, Labcorp (NYSE: LH), Morningside Ventures, Lightchain Capital, NT Investments, Granger Management and Mercy Health, Tri Locum Partners, and others...Bio-Rad leads investment to support the launch of ColoSense®, a non-invasive colorectal cancer screening test, and advance diagnostic innovations for inflammatory bowel disease"

"Geneoscopy, Inc...announced that Erica Barnell, MD, PhD, Geneoscopy’s Chief Medical & Science Officer, will present two important topics in November, showcasing her work as a woman leader in the sciences, as well as an update on advancements in colorectal cancer (CRC) screening and early detection...'I look forward to sharing my journey in biotech, where diverse voices and perspectives have been instrumental in building Geneoscopy. At the AGA Workshop, I will have the opportunity to collaborate with esteemed colleagues to explore advancements in colorectal cancer screening, providing a unique opportunity to strengthen clinical pathways that can drive early detection and save lives.' More than 44 million Americans at average risk for CRC remain unscreened despite screening’s vital role in early detection and prevention. Access to reliable options for screening enhances the ability to detect disease early and provides valuable information to guide personalized..."

"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; 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.

"Geneoscopy, Inc...announced the publication of a study in The Journal of Molecular Diagnostics, highlighting the analytical validation of ColoSense™, a noninvasive, multi-target stool RNA (mt-sRNA) screening test for colorectal cancer (CRC) and advanced adenomas (AAs) in average-risk individuals aged 45 and older."

"A second poster presentation...demonstrated a preliminary ability to leverage bio-banked stool samples to improve the accuracy of Geneoscopy’s RNA-based ColoSense test, which recently received FDA approval for CRC screening of average-risk individuals over the age of 45. Novel stool-based RNA biomarkers improved sensitivity for detecting CRC and advanced adenomas while maintaining high specificity for no lesions on colonoscopy. Ongoing efforts aim to enhance the ColoSense performance by identifying novel biomarkers to further refine its diagnostic accuracy utilizing next-generation sequencing technology."

"Geneoscopy...announced that the U.S. Food and Drug Administration (FDA) approved its noninvasive colorectal cancer screening test, ColoSense. ColoSense is indicated as a screening test for adults, 45 years of age or older, who are at typical average risk for developing CRC....The CRC-PREVENT study evaluated more than 1,800 average-risk individuals aged 45-49, representing over 20% of participants. Results in this subgroup showed 100% sensitivity in detecting CRC and 44% sensitivity for AA, offering a promising new tool to combat early-age onset CRC."