Latest news with #ColoSense
Business Wire
5 days ago
- Business
- Business Wire
Geneoscopy Wins Patent Trial and Appeal Board Decision, Invalidating All 20 Claims of Exact Sciences' '781 Patent
ST. LOUIS, Mo.--(BUSINESS WIRE)-- Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, today announced that the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office has issued a Final Written Decision following inter partes review (IPR), finding all 20 challenged claims of U.S. Patent No. 11,634,781 (the '781 patent) unpatentable. The PTAB's ruling concluded that all claims of the '781 patent are obvious considering prior art related to stool sample collection and processing. The decision to invalidate the '781 patent confirms Geneoscopy's long-held position and clears the path for the continued commercialization of ColoSense. 'The PTAB's final decision validates what we have believed all along—that the claims in the '781 patent should never have been issued,' said Andrew Barnell, CEO and co-founder of Geneoscopy. 'This outcome not only reinforces the strength of our position but helps ensure that invalid patents cannot be used to limit patient access to life-saving colorectal cancer screening options like ColoSense. It's a critical step toward protecting patient choice and advancing high-quality, noninvasive screening solutions.' Geneoscopy filed the IPR petition after Exact Sciences initiated a patent infringement suit in the U.S. District Court for the District of Delaware. The PTAB's ruling bolsters the company's defenses in that case and follows the Board's earlier decision in February to institute review of a second patent asserted by Exact Sciences (U.S. Patent No. 11,970,746) on largely the same grounds on which the '781 patent was just invalidated. In parallel to the pending litigation, Geneoscopy has filed a countersuit alleging breach of contract, misappropriation of trade secrets, false advertising, and unfair competition. 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.
Associated Press
24-06-2025
- Health
- Associated Press
Modeling Study Published in Clinical Gastroenterology and Hepatology Validates Geneoscopy's ColoSense® Real-World Screening Impact
ST. LOUIS--(BUSINESS WIRE)--Jun 24, 2025-- Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, 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. In the absence of a head-to-head study comparing CRC screening options, this peer-reviewed modeling study, titled 'Cost-effectiveness of novel noninvasive screening tests for colorectal neoplasia,' provides valuable insights by evaluating five CRC screening strategies for patients aged 45 and older. Using a 10-year Markov model, researchers simulated disease progression, comparing mt-sRNA, two mt-sDNA tests, a blood-based test, and a fecal immunochemical test (FIT), and reported findings similar to previously published modeling studies. 1-3 When test performance was normalized to better reflect the age of the intended use population, the clinical and economic benefits of ColoSense were amplified. At real-world adherence of 60% (the typical rate observed in practice), the modeling study results showed that ColoSense reduced CRC deaths by 14% compared to FIT, by 19% and 23% compared to the mt-sDNA tests, and by 86% compared to a blood-based test. 1 While FIT remained the most cost-effective strategy overall, ColoSense was the most cost-effective among molecular tests across all levels of screening adherence. 'Study cohorts often don't reflect the target patient population, which can skew results and limit clinical relevance,' said Dr. Erica Barnell, co-author and Chief Science and Medical Officer at Geneoscopy. 'These data reinforce the need to design studies around real-world populations. ColoSense was developed with that in mind, delivering strong performance across diverse groups, including younger adults who are often under-represented in clinical trials.' This study builds on prior research by using a model that normalizes the age of the populations in independent, peer-reviewed studies to better reflect the general screening population. Given that many assays rely on methylation-based biomarkers, whose sensitivity is lower in younger individuals, 4,5 adjusting sensitivity estimates for colorectal cancer and advanced adenomas is essential for accurate clinical and economic assessment. ColoSense is included in the 2025 National Comprehensive Cancer Network (NCCN) guideline update, highlighting the strength of its clinical evidence and the robust science behind Geneoscopy's RNA-based approach. As the only FDA-approved stool RNA test for CRC screening, ColoSense represents a significant step forward in noninvasive screening methods, underscoring the need for accessible alternatives that can increase compliance, especially among groups less likely to pursue colonoscopy. *All data used in the study were derived from independent, non-head-to-head clinical trial results. 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: UNITED STATES NORTH AMERICA MISSOURI INDUSTRY KEYWORD: SCIENCE BIOTECHNOLOGY RESEARCH MANAGED CARE ONCOLOGY HEALTH GENETICS CLINICAL TRIALS SOURCE: Geneoscopy, Inc. Copyright Business Wire 2025. PUB: 06/24/2025 08:05 AM/DISC: 06/24/2025 08:04 AM
Business Wire
24-06-2025
- Health
- Business Wire
Modeling Study Published in Clinical Gastroenterology and Hepatology Validates Geneoscopy's ColoSense® Real-World Screening Impact
ST. LOUIS--(BUSINESS WIRE)-- Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, 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. In the absence of a head-to-head study comparing CRC screening options, this peer-reviewed modeling study, titled ' Cost-effectiveness of novel noninvasive screening tests for colorectal neoplasia,' provides valuable insights by evaluating five CRC screening strategies for patients aged 45 and older. Using a 10-year Markov model, researchers simulated disease progression, comparing mt-sRNA, two mt-sDNA tests, a blood-based test, and a fecal immunochemical test (FIT), and reported findings similar to previously published modeling studies. 1-3 When test performance was normalized to better reflect the age of the intended use population, the clinical and economic benefits of ColoSense were amplified. At real-world adherence of 60% (the typical rate observed in practice), the modeling study results showed that ColoSense reduced CRC deaths by 14% compared to FIT, by 19% and 23% compared to the mt-sDNA tests, and by 86% compared to a blood-based test. 1 While FIT remained the most cost-effective strategy overall, ColoSense was the most cost-effective among molecular tests across all levels of screening adherence. 'Study cohorts often don't reflect the target patient population, which can skew results and limit clinical relevance,' said Dr. Erica Barnell, co-author and Chief Science and Medical Officer at Geneoscopy. 'These data reinforce the need to design studies around real-world populations. ColoSense was developed with that in mind, delivering strong performance across diverse groups, including younger adults who are often under-represented in clinical trials.' This study builds on prior research by using a model that normalizes the age of the populations in independent, peer-reviewed studies to better reflect the general screening population. Given that many assays rely on methylation-based biomarkers, whose sensitivity is lower in younger individuals, 4,5 adjusting sensitivity estimates for colorectal cancer and advanced adenomas is essential for accurate clinical and economic assessment. ColoSense is included in the 2025 National Comprehensive Cancer Network (NCCN) guideline update, highlighting the strength of its clinical evidence and the robust science behind Geneoscopy's RNA-based approach. As the only FDA-approved stool RNA test for CRC screening, ColoSense represents a significant step forward in noninvasive screening methods, underscoring the need for accessible alternatives that can increase compliance, especially among groups less likely to pursue colonoscopy. *All data used in the study were derived from independent, non-head-to-head clinical trial results. 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 Shaukat A, Levin TR, Liang PS, Weiss JM, Smare C, Boller E, Venkatachalam M, Barnell EK. Cost-effectiveness of novel noninvasive screening tests for colorectal neoplasia. Clinical Gastroenterology and Hepatology. 2025. doi: Ladabaum U, Mannalithara A, Schoen RE, Dominitz JA, Lieberman D. Projected impact and cost-effectiveness of novel molecular blood-based or stool-based screening tests for colorectal cancer. Ann Intern Med. 2024;177(12):1610-1620. doi: 10.7326/ANNALS-24-00910. Epub 2024 Oct 29. PMID: 39467291. Rui M, Wang Y, You JH. Novel non-invasive tests for colorectal cancer screening - a cost-effectiveness analysis. Cancer Epidemiol Biomarkers Prev. 2025;OF1–OF11. doi:10.1158/ Ahlquist DA, Taylor WR, Yab TC, Devens ME, Mahoney DW, Boardman LA, Thibodeau SN, et al. Abstract 3572: Methylated gene marker levels in stool: Effects of demographic, drug, and body mass and other patient characteristics. Cancer Research. 2012;72(8_Supplement):3572–3572. Ahlquist DA, Taylor WR, Yab TC, Devens ME, Mahoney DW, et al. Aberrantly methylated gene marker levels in stool: effects of demographic, exposure, body mass, and other patient characteristics. J Mol Biomark Diagn
Yahoo
24-06-2025
- Health
- Yahoo
Modeling Study Published in Clinical Gastroenterology and Hepatology Validates Geneoscopy's ColoSense® Real-World Screening Impact
ST. LOUIS, June 24, 2025--(BUSINESS WIRE)--Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, 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. In the absence of a head-to-head study comparing CRC screening options, this peer-reviewed modeling study, titled "Cost-effectiveness of novel noninvasive screening tests for colorectal neoplasia," provides valuable insights by evaluating five CRC screening strategies for patients aged 45 and older. Using a 10-year Markov model, researchers simulated disease progression, comparing mt-sRNA, two mt-sDNA tests, a blood-based test, and a fecal immunochemical test (FIT), and reported findings similar to previously published modeling studies.1-3 When test performance was normalized to better reflect the age of the intended use population, the clinical and economic benefits of ColoSense were amplified. At real-world adherence of 60% (the typical rate observed in practice), the modeling study results showed that ColoSense reduced CRC deaths by 14% compared to FIT, by 19% and 23% compared to the mt-sDNA tests, and by 86% compared to a blood-based test.1 While FIT remained the most cost-effective strategy overall, ColoSense was the most cost-effective among molecular tests across all levels of screening adherence. "Study cohorts often don't reflect the target patient population, which can skew results and limit clinical relevance," said Dr. Erica Barnell, co-author and Chief Science and Medical Officer at Geneoscopy. "These data reinforce the need to design studies around real-world populations. ColoSense was developed with that in mind, delivering strong performance across diverse groups, including younger adults who are often under-represented in clinical trials." This study builds on prior research by using a model that normalizes the age of the populations in independent, peer-reviewed studies to better reflect the general screening population. Given that many assays rely on methylation-based biomarkers, whose sensitivity is lower in younger individuals,4,5 adjusting sensitivity estimates for colorectal cancer and advanced adenomas is essential for accurate clinical and economic assessment. ColoSense is included in the 2025 National Comprehensive Cancer Network (NCCN) guideline update, highlighting the strength of its clinical evidence and the robust science behind Geneoscopy's RNA-based approach. As the only FDA-approved stool RNA test for CRC screening, ColoSense represents a significant step forward in noninvasive screening methods, underscoring the need for accessible alternatives that can increase compliance, especially among groups less likely to pursue colonoscopy. *All data used in the study were derived from independent, non-head-to-head clinical trial results. 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 Shaukat A, Levin TR, Liang PS, Weiss JM, Smare C, Boller E, Venkatachalam M, Barnell EK. Cost-effectiveness of novel noninvasive screening tests for colorectal neoplasia. Clinical Gastroenterology and Hepatology. 2025. doi: Ladabaum U, Mannalithara A, Schoen RE, Dominitz JA, Lieberman D. Projected impact and cost-effectiveness of novel molecular blood-based or stool-based screening tests for colorectal cancer. Ann Intern Med. 2024;177(12):1610-1620. doi: 10.7326/ANNALS-24-00910. Epub 2024 Oct 29. PMID: 39467291. Rui M, Wang Y, You JH. Novel non-invasive tests for colorectal cancer screening - a cost-effectiveness analysis. Cancer Epidemiol Biomarkers Prev. 2025;OF1–OF11. doi:10.1158/ Ahlquist DA, Taylor WR, Yab TC, Devens ME, Mahoney DW, Boardman LA, Thibodeau SN, et al. Abstract 3572: Methylated gene marker levels in stool: Effects of demographic, drug, and body mass and other patient characteristics. Cancer Research. 2012;72(8_Supplement):3572–3572. Ahlquist DA, Taylor WR, Yab TC, Devens ME, Mahoney DW, et al. Aberrantly methylated gene marker levels in stool: effects of demographic, exposure, body mass, and other patient characteristics. J Mol Biomark Diagn. 2012;3:133. doi:10.4172/2155-9929.1000133. View source version on Contacts Media Contact Andrea SampsonSampson Public Relations Groupasampson@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Associated Press
03-06-2025
- 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
