TEST:

ColoSense™

"Geneoscopy, Inc...today announced new peer-reviewed data in Practical Laboratory Medicine validating the analytical reliability of the scrape-free collection method used in its ColoSense® colorectal cancer (CRC) screening test. The method, which eliminates patient handling of stool and standardizes testing in the laboratory, will be highlighted at the American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting on Monday, Oct. 27, 2025"

Analytical validation of the in-lab FIT demonstrates the reliability and robustness of this streamlined, single-sample collection method. This improvement could enhance adherence and patient ease-of-use in stool-based CRC screening.

"Geneoscopy, Inc...today announced that Exact Sciences has withdrawn its motion for a preliminary injunction regarding U.S. Patent No. 11,634,781 (“the ‘781 patent”) and U.S. Patent No. 11,970,746 (“the ‘746 patent”)."

"Geneoscopy...today announced the publication of a new study in Clinical Gastroenterology and Hepatology showing that its FDA-approved multitarget stool RNA (mt-sRNA) test, ColoSense®, achieved notable clinical benefits among colorectal cancer (CRC) screening tests when modeled at real-world adherence levels."

FIT was the most cost-effective strategy for preventing CRC cases and deaths. At real-world adherence of 60%, mt-sRNA demonstrated the greatest clinical benefit and was more cost-effective than other molecular strategies.

"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."