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Geneoscopy's RNA-Based ColoSense Test Included in Latest National Comprehensive Cancer Network (NCCN) Guidelines
Geneoscopy's RNA-Based ColoSense Test Included in Latest National Comprehensive Cancer Network (NCCN) Guidelines

Associated Press

time3 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

Geneoscopy's RNA-Based ColoSense Test Included in Latest National Comprehensive Cancer Network (NCCN) Guidelines
Geneoscopy's RNA-Based ColoSense Test Included in Latest National Comprehensive Cancer Network (NCCN) Guidelines

Business Wire

time3 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

Geneoscopy Sibling Co-founders Named Finalists for EY Entrepreneur Of The Year 2025 Heartland Award
Geneoscopy Sibling Co-founders Named Finalists for EY Entrepreneur Of The Year 2025 Heartland Award

Yahoo

time29-04-2025

  • Business
  • Yahoo

Geneoscopy Sibling Co-founders Named Finalists for EY Entrepreneur Of The Year 2025 Heartland Award

Entrepreneur Of The Year celebrates ambitious entrepreneurs who are shaping the future ST. LOUIS, April 29, 2025--(BUSINESS WIRE)--Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, today announced that co-founders Andrew Barnell, MBA, and Erica Barnell, M.D., Ph.D., have been named finalists for the Ernst & Young (EY) Entrepreneur Of The Year® 2025 Heartland Award. Entrepreneur Of The Year is one of the preeminent competitive business awards recognizing leaders of high-growth companies that are creating a better future through innovation, purpose, and transformative impact. This recognition places Geneoscopy's co-founders alongside entrepreneurs and leaders in the Heartland region, which includes Minnesota, Kansas, Missouri, Iowa, Nebraska, North Dakota, and South Dakota. "Being named a finalist is a testament to the hard work of Geneoscopy's entire team," said Andrew Barnell, CEO of Geneoscopy. "Erica and I have always focused on building a strong business foundation—scaling our operations, hiring the right people to advance our mission and technology, establishing key partnerships, and setting the stage for long-term growth. We're honored to be recognized by EY among such an inspiring group of entrepreneurs." Erica and Andrew's leadership and vision have been instrumental in Geneoscopy's growth and advancement of non-invasive diagnostics for gastrointestinal health. Through the development of its novel platform for isolating human RNA from stool samples, Geneoscopy has developed FDA-approved ColoSense®, a highly effective screening solution for colorectal cancer. The company is also expanding its diagnostic pipeline to address critical unmet needs in inflammatory bowel disease. "Building Geneoscopy with my brother has been an incredible journey," said Erica Barnell, M.D., Ph.D., Chief Science and Medical Officer of Geneoscopy. "From early research efforts to developing a clinically validated technology, it has been deeply rewarding to see our vision translate into real-world impact for patients." Regional award winners will be announced on Thursday, June 19, during a special celebration in Minneapolis. Finalists become lifetime members of an esteemed community of Entrepreneur Of The Year alumni from around the world. The winners will then be considered by the National judges for the Entrepreneur Of The Year National Awards, which will be presented in November at the annual Strategic Growth Forum®, one of the nation's most prestigious gatherings of high-growth, market-leading companies. 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. Sponsors Founded and produced by Ernst & Young LLP, the Entrepreneur Of The Year Awards include presenting sponsors PNC Bank, Cresa, LLC, Marsh USA and SAP. In the Heartland, sponsors also include Twin Cities Business, Padilla and Brillect. About Entrepreneur Of The Year Founded in 1986, Entrepreneur Of The Year has celebrated more than 11,000 ambitious visionaries who are leading successful, dynamic businesses in the US, and it has since expanded to nearly 60 countries globally. The US program consists of 17 regional programs whose panels of independent judges select the regional award winners every June. Those winners compete for national recognition at the Strategic Growth Forum® in November where National finalists and award winners are announced. The overall National winner represents the US at the EY World Entrepreneur Of The Year™ competition. Visit About EY EY is building a better working world by creating new value for clients, people, society and the planet, while building trust in capital markets. Enabled by data, AI and advanced technology, EY teams help clients shape the future with confidence and develop answers for the most pressing issues of today and tomorrow. EY teams work across a full spectrum of services in assurance, consulting, tax, strategy and transactions. Fueled by sector insights, a globally connected, multi-disciplinary network and diverse ecosystem partners, EY teams can provide services in more than 150 countries and territories. All in to shape the future with confidence. EY refers to the global organization, and may refer to one or more, of the member firms of Ernst & Young Global Limited, each of which is a separate legal entity. Ernst & Young Global Limited, a UK company limited by guarantee, does not provide services to clients. Information about how EY collects and uses personal data and a description of the rights individuals have under data protection legislation are available via EY member firms do not practice law where prohibited by local laws. For more information about our organization, please visit View source version on Contacts Media Andrea SampsonSampson Public Relations Groupasampson@

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