COMPANY:

Geneoscopy

"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."

"Geneoscopy Inc…announced the enrollment of its first patients in the CRC-PREVENT pivotal trial. The clinical study seeks to evaluate the safety and efficacy of Geneoscopy's noninvasive, at-home diagnostic screening test to successfully detect colorectal neoplasms, including advanced adenomas, in average-risk individuals, a group with no known co-morbidities associated with cancer risk and therefore more challenging to diagnose….The prospective, single-arm study will enroll more than 12,000 patients across all 48 contiguous United States."