Latest news with #ColoSense
Associated Press
3 days ago
- Business
- Associated Press
Geneoscopy's RNA-Based ColoSense Test Included in Latest National Comprehensive Cancer Network (NCCN) Guidelines
ST. LOUIS--(BUSINESS WIRE)--Jun 3, 2025-- Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, today announced that its ColoSense® test has been included in the National Comprehensive Cancer Network® (NCCN) Guidelines for Colorectal Cancer (CRC) Screening as a first-line test for average-risk patients, supporting its role as a screening alternative for individuals aged 45 years and older. ColoSense is a noninvasive stool-based test for detecting CRC and advanced adenomas, and is the only FDA-approved screening test utilizing stool RNA biomarkers, which are not subject to age-related methylation. 1,2 The NCCN Guidelines are comprehensive, evidence-based recommendations to support the prevention, diagnosis, and treatment of more than 97% of cancers affecting patients in the United States. They are regularly updated to reflect the latest scientific evidence and improve the quality and consistency of cancer care. 'The NCCN Guidelines are among the most trusted clinical resources in oncology, and the addition of ColoSense is a powerful validation of its clinical performance,' said Erica Barnell, M.D., Ph.D., Chief Science and Medical Officer of Geneoscopy. 'As the first and only FDA-approved stool RNA screening test for colorectal cancer, this affirms the scientific rigor behind our technology and reinforces the importance of noninvasive modalities in expanding access and improving screening compliance, especially among populations less likely to undergo colonoscopy.' ColoSense's inclusion in the NCCN Guidelines is based on data from Geneoscopy's CRC-PREVENT pivotal study, which was published in the Journal of the American Medical Association (JAMA). 3 Unlike traditional centralized trials, in which patients are typically already engaged in healthcare screening programs, nearly two-thirds of CRC-PREVENT participants had never undergone CRC screening or scheduled a colonoscopy at the time of enrollment. The study demonstrated ColoSense's ability to detect CRC with 94% sensitivity, identifying 100% of CRC in Stage I. Additionally, ColoSense detected 46% of advanced adenomas, when the disease is most preventable. 'The NCCN Guidelines heavily impact both the clinical adoption and insurance coverage of screening tests,' said Matt Sargent, Chief Commercial Officer of Geneoscopy. 'Achieving this milestone as a first-line test marks a pivotal step forward in our mission to bring ColoSense to market as an accurate, accessible screening solution for millions of Americans. NCCN guideline inclusion also positions ColoSense for future inclusion in other major guidelines.' About ColoSense ColoSense is intended for the qualitative detection of colorectal neoplasia-associated RNA markers and for the presence of occult hemoglobin in human stool. ColoSense is for use with the ColoSense Collection Kit, the ColoSense Test Kit, the ColoSense Software, and the following instruments: Polymedco iFOBT Analyzer; bioMérieux EMAG Nucleic Acid Extraction System; and Bio-Rad QXDx ddPCR System. ColoSense is a single-site test performed at Geneoscopy, Inc. A positive ColoSense result may indicate the presence of colorectal cancer (CRC), advanced adenomas (AA), or serrated precancerous lesions (SPL) and should be followed by a colonoscopy. ColoSense is indicated as a screening test for adults aged 45 years or older who are at the typical average risk for developing CRC. ColoSense is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals. Results from Geneoscopy's pivotal CRC-PREVENT trial were published in The Journal of the American Medical Association (JAMA) in October 2023. For more information, visit About Geneoscopy, Inc. Geneoscopy, Inc. is a life sciences company focused on developing diagnostic tests for gastrointestinal health. Leveraging its proprietary, patented stool-derived eukaryotic RNA (seRNA) biomarker platform, Geneoscopy's mission is to empower patients and providers to transform gastrointestinal health through innovative diagnostics. The company's FDA-approved ColoSense test uses a proprietary RNA-based platform to screen for colorectal cancer and advanced adenomas for average-risk individuals over the age of 45. In partnership with leading universities and biopharmaceutical companies, Geneoscopy is also developing diagnostic tests for treatment selection and therapy monitoring in other areas of gastrointestinal health. For more information, visit and follow the company on LinkedIn. References View source version on CONTACT: Media Contact Andrea Sampson Sampson Public Relations Group [email protected] KEYWORD: MISSOURI UNITED STATES NORTH AMERICA INDUSTRY KEYWORD: SCIENCE OTHER SCIENCE BIOTECHNOLOGY RESEARCH MANAGED CARE ONCOLOGY HEALTH GENETICS SOURCE: Geneoscopy, Inc. Copyright Business Wire 2025. PUB: 06/03/2025 07:50 AM/DISC: 06/03/2025 07:50 AM
Business Wire
3 days ago
- Business
- Business Wire
Geneoscopy's RNA-Based ColoSense Test Included in Latest National Comprehensive Cancer Network (NCCN) Guidelines
ST. LOUIS--(BUSINESS WIRE)-- Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, today announced that its ColoSense® test has been included in the National Comprehensive Cancer Network® (NCCN) Guidelines for Colorectal Cancer (CRC) Screening as a first-line test for average-risk patients, supporting its role as a screening alternative for individuals aged 45 years and older. ColoSense is a noninvasive stool-based test for detecting CRC and advanced adenomas, and is the only FDA-approved screening test utilizing stool RNA biomarkers, which are not subject to age-related methylation. 1,2 The NCCN Guidelines are comprehensive, evidence-based recommendations to support the prevention, diagnosis, and treatment of more than 97% of cancers affecting patients in the United States. They are regularly updated to reflect the latest scientific evidence and improve the quality and consistency of cancer care. 'The NCCN Guidelines are among the most trusted clinical resources in oncology, and the addition of ColoSense is a powerful validation of its clinical performance,' said Erica Barnell, M.D., Ph.D., Chief Science and Medical Officer of Geneoscopy. 'As the first and only FDA-approved stool RNA screening test for colorectal cancer, this affirms the scientific rigor behind our technology and reinforces the importance of noninvasive modalities in expanding access and improving screening compliance, especially among populations less likely to undergo colonoscopy.' ColoSense's inclusion in the NCCN Guidelines is based on data from Geneoscopy's CRC-PREVENT pivotal study, which was published in the Journal of the American Medical Association (JAMA). 3 Unlike traditional centralized trials, in which patients are typically already engaged in healthcare screening programs, nearly two-thirds of CRC-PREVENT participants had never undergone CRC screening or scheduled a colonoscopy at the time of enrollment. The study demonstrated ColoSense's ability to detect CRC with 94% sensitivity, identifying 100% of CRC in Stage I. Additionally, ColoSense detected 46% of advanced adenomas, when the disease is most preventable. 'The NCCN Guidelines heavily impact both the clinical adoption and insurance coverage of screening tests,' said Matt Sargent, Chief Commercial Officer of Geneoscopy. 'Achieving this milestone as a first-line test marks a pivotal step forward in our mission to bring ColoSense to market as an accurate, accessible screening solution for millions of Americans. NCCN guideline inclusion also positions ColoSense for future inclusion in other major guidelines.' About ColoSense ColoSense is intended for the qualitative detection of colorectal neoplasia-associated RNA markers and for the presence of occult hemoglobin in human stool. ColoSense is for use with the ColoSense Collection Kit, the ColoSense Test Kit, the ColoSense Software, and the following instruments: Polymedco iFOBT Analyzer; bioMérieux EMAG Nucleic Acid Extraction System; and Bio-Rad QXDx ddPCR System. ColoSense is a single-site test performed at Geneoscopy, Inc. A positive ColoSense result may indicate the presence of colorectal cancer (CRC), advanced adenomas (AA), or serrated precancerous lesions (SPL) and should be followed by a colonoscopy. ColoSense is indicated as a screening test for adults aged 45 years or older who are at the typical average risk for developing CRC. ColoSense is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals. Results from Geneoscopy's pivotal CRC-PREVENT trial were published in The Journal of the American Medical Association (JAMA) in October 2023. For more information, visit About Geneoscopy, Inc. Geneoscopy, Inc. is a life sciences company focused on developing diagnostic tests for gastrointestinal health. Leveraging its proprietary, patented stool-derived eukaryotic RNA (seRNA) biomarker platform, Geneoscopy's mission is to empower patients and providers to transform gastrointestinal health through innovative diagnostics. The company's FDA-approved ColoSense test uses a proprietary RNA-based platform to screen for colorectal cancer and advanced adenomas for average-risk individuals over the age of 45. In partnership with leading universities and biopharmaceutical companies, Geneoscopy is also developing diagnostic tests for treatment selection and therapy monitoring in other areas of gastrointestinal health. For more information, visit and follow the company on LinkedIn. References Ahlquist, D. A., Taylor, W. R., Yab, T. C., Devens, M. E., Mahoney, D. W., Boardman, L. A., Thibodeau, S. N., Zou, H., Michael, D., Berger, B. M., & Lidgard, G. P. (2012). Abstract 3572: Methylated gene marker levels in stool: Effects of demographic, drug, and body mass and other patient characteristics. Cancer Research, 72(8_Supplement), 3572–3572. Ahlquist DA, Taylor WR, Yab TC, Devens ME, Mahoney DW, et al. (2012) Aberrantly Methylated Gene Marker Levels in Stool: Effects of Demographic, Exposure, Body Mass, and Other Patient Characteristics. J Mol Biomark Diagn 3:133. doi:10.4172/2155-9929.1000133 Barnell EK, Wurtzler EM, La Rocca J, et al. Multitarget Stool RNA Test for Colorectal Cancer Screening. JAMA. 2023;330(18):1760–1768. doi:10.1001/jama.2023.22231
Yahoo
18-02-2025
- Business
- Yahoo
U.S. Patent Trial and Appeal Board Institutes Inter Partes Review Based on Geneoscopy's Petition Challenging Validity of a Second Patent Asserted by Exact Sciences
ST. LOUIS, February 18, 2025--(BUSINESS WIRE)--Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, today announced that the U.S. Patent Trial and Appeal Board (PTAB) has instituted inter partes review (IPR) of U.S. Patent No. 11,970,746 ("the '746 patent") owned by Exact Sciences. After reviewing Geneoscopy's petition, the supporting evidence, and Exact Sciences' arguments in response, the PTAB determined that Geneoscopy has shown a reasonable likelihood of prevailing on its assertion that the challenged claims of Exact Sciences' '746 patent are unpatentable as obvious over the prior art. Previously, the PTAB instituted an IPR to review the claims of another patent ('781 Patent) owned by Exact Sciences based on Geneoscopy's petition challenging the validity of the '781 Patent. Both decisions are publicly available on the PTAB website. "The PTAB's decision to institute an IPR against the '746 patent, following its July 2024 institution of an IPR against the '781 patent, means the PTAB has found it likely that both patents Exact Sciences has asserted in court against Geneoscopy are invalid," said Andrew Barnell, CEO and co-founder of Geneoscopy. "We are confident that the asserted claims of these patents are unpatentable. These decisions reinforce our position and pave the way for Geneoscopy's launch of ColoSense®, which will bring a new colorectal cancer screening option to the market to increase access to effective and convenient testing that has the potential to save lives." Geneoscopy filed its second IPR petition after Exact Sciences alleged infringement of the '746 patent in a lawsuit filed in the U.S. District Court for the District of Delaware. As with the first petition of the '781 patent, Geneoscopy explained that nothing in the '746 patent is inventive, the method is obvious, and the challenged claims are invalid. The PTAB's decision further strengthens Geneoscopy's defenses to Exact Sciences' allegations in the lawsuit. Geneoscopy has also filed a countersuit against Exact Sciences, alleging breach of contract, misappropriation of trade secrets, and various violations of state and federal law. About Geneoscopy, Inc. Geneoscopy, Inc. is a life sciences company focused on developing diagnostic tests for gastrointestinal health. Leveraging its proprietary, patented stool-derived eukaryotic RNA (seRNA) biomarker platform, Geneoscopy's mission is to empower patients and providers to transform gastrointestinal health through innovative diagnostics. The company's FDA-approved ColoSense test uses a proprietary RNA-based platform to screen for colorectal cancer and advanced adenomas for average-risk individuals over the age of 45. In partnership with leading universities and biopharmaceutical companies, Geneoscopy is also developing diagnostic tests for treatment selection and therapy monitoring in other areas of gastrointestinal health. For more information, visit and follow the company on LinkedIn. View source version on Contacts Media Contact Andrea SampsonSampson Public Relations Groupasampson@
