COMPANY:

Geneoscopy

"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.."

"Geneoscopy, Inc...announced that Erica Barnell, MD, PhD, Geneoscopy’s Chief Medical & Science Officer, will present at two important healthcare conferences, showcasing advancements in colorectal cancer (CRC) screening and early detection...The presentation will shed light on the latest data and perspectives on blood-based CRC screening tests and examine recent clinical trial results."

"Geneoscopy, Inc...announced that the U.S. Patent Trial and Appeal Board (PTAB) has instituted inter partes review (IPR) to review the patentability of U.S. Patent No. 11,634,781 (“the ‘781 patent”) owned by Exact Sciences."

"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."

"Geneoscopy announced Monday that it has filed a lawsuit against Exact Sciences in federal court in Delaware in relation to a patent that is central to both companies' colorectal cancer screening tests."

"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."

"Geneoscopy, Inc...announced that it has petitioned the United States Patent and Trademark Office (USPTO) for inter partes review challenging the patentability of United States Patent No. 11,634,781 ('the ’781 patent') owned by Exact Sciences...The petition explains that the claims of the ’781 patent are directed to the separation of a fecal sample into two portions to permit two standard diagnostic tests – one detecting blood proteins and the other detecting nucleic acids – to be performed on the sample."

"Exact Sciences Corp...announced that it has filed a lawsuit against Geneoscopy, Inc. in the United States District Court for the District of Delaware."

"Geneoscopy Inc...today announced a strategic collaboration with Labcorp...This multi-year agreement will increase access to Geneoscopy’s next-generation colorectal cancer screening test, which offers at-home collection and high sensitivity for early cancer detection. Geneoscopy's test is under FDA review. Once approved by the FDA, Labcorp will offer the test, which will be performed by Geneoscopy, enabling health care customers to conveniently order it through Labcorp as part of their comprehensive screening programs."

"Geneoscopy Inc...announced a publication in The Journal of the American Medical Association (JAMA), highlighting the company’s pivotal CRC-PREVENT trial results. The novel study will be presented at the American College of Gastroenterology (ACG) Annual Scientific Meeting in Vancouver, Canada, October 20-25, showcasing its highly sensitive screening test for colorectal cancer (CRC) and advanced adenomas (AA)."

"Geneoscopy Inc...will present at the American College of Gastroenterology (ACG) 2023 Annual Scientific Meeting in Vancouver, Canada, Oct. 20-25, highlighting how its novel platform technology is being used to develop noninvasive diagnostic and precision medicine tools for gastrointestinal (GI) diseases, such as colorectal cancer (CRC) and inflammatory bowel disease (IBD). The company will also feature its technology at booth #908."

"Geneoscopy, Inc....announced the assignment of a unique DEX Z-code from Palmetto GBA’s MolDX program for the company’s noninvasive multi-target stool RNA (mt-sRNA) colorectal cancer screening test...The assignment of the DEX Z-code as a test identifier is a significant step as Geneoscopy awaits the US Food and Drug Administration’s decision regarding the PMA submitted in January 2023."

"Geneoscopy, Inc...announced...it submitted a Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its noninvasive, stool-based, at-home screening test to detect colorectal cancer (CRC) and advanced adenomas (AA) in average-risk individuals. The FDA designated the test as a Breakthrough Device in January 2021."

P=NA | N=10,000 | NCT04739722 | Sponsor: Geneoscopy, Inc. | "Geneoscopy...announced favorable results from the CRC-PREVENT trial – a pivotal clinical trial evaluating the efficacy of its noninvasive, stool-based, at-home diagnostic screening test to detect colorectal cancer (CRC) and advanced adenomas (AA) in average-risk individuals. In the trial, Geneoscopy's stool-based screening test met the clinical endpoints across all primary outcome measures, including sensitivity and specificity for CRC and AA....Geneoscopy's test is not yet available for sale and is not yet approved by the U.S. Food and Drug Administration (FDA). A Premarket Approval submission to the FDA is planned for the first quarter of 2023."

"Geneoscopy, Inc...announced that the Accreditation Committee of the College of American Pathologists (CAP) has accredited the Company's Ph.D. clinical laboratory facility at its headquarters in St. Louis. This achievement follows a recent on-site inspection as part of the CAP Laboratory Accreditation Program...As part of the certification process, Geneoscopy completed analytical and clinical validation evaluating the accuracy and reliability of its patented colorectal cancer diagnostics platform."

"Geneoscopy Inc...announced completed enrollment of the CRC-PREVENT pivotal trial for its noninvasive, at-home diagnostic screening test to detect colorectal cancer (CRC) and advanced adenomas in average-risk individuals. Through a decentralized recruitment strategy, Geneoscopy enrolled more than 14,000 individuals across all 48 continental United States, many from traditionally under-represented communities in clinical trials, in terms of gender, race, ethnicity, socioeconomic status, and geography."

"Geneoscopy Inc...announced findings from an early cost-effectiveness modeling study that aimed to assess the total costs and health outcomes associated with the use of an investigational RNA-FIT biomarker panel versus multi-target stool DNA (mt-sDNA), fecal immunochemical test (FIT), and colonoscopy alone for the screening of colorectal cancer (CRC). Geneoscopy's RNA-FIT test is being evaluated as a potential noninvasive, at-home diagnostic screening test to detect colorectal neoplasms, including advanced adenomas, in average-risk individuals. The data was highlighted in a poster at the 2022 Digestive Disease Week meeting being held in San Diego from May 21-24."

"Geneoscopy Inc...announced clinical trial recruitment findings from the CRC-PREVENT pivotal trial evaluating the safety and efficacy of its noninvasive, at-home diagnostic screening test to detect colorectal neoplasms, including advanced adenomas, in average-risk individuals. The data was highlighted in a poster at the 2022 ASCO Gastrointestinal Cancers Symposium being held in San Francisco from January 20-22."

"Geneoscopy Inc., a life sciences company focused on the development of diagnostic tests for gastrointestinal health, today announced the closing of a Series B financing, raising a total of $105 million through a combination of debt and equity...Unlike other noninvasive screening options that use DNA or blood-based biomarkers, Geneoscopy's proprietary method analyzes RNA extracted from patient stool samples to provide the phenotypic and quantitative information necessary to accurately detect precancerous lesions."