- Dr. Turgeon is an esteemed clinical professor at the University of Michigan Health and a translational clinical researcher with a specific research interest in colon cancer and chemoprevention
- Mainz Biomed’s Medical Advisory Board will bring together a highly distinguished group of multidisciplinary experts from gastroenterology, clinical research and diagnostics to support its upcoming U.S. pivotal trial for ColoAlert
BERKELEY, Calif. and MAINZ, Germany, Aug. 23, 2022 (GLOBE NEWSWIRE) — Mainz Biomed NV (NASDAQ: MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetic diagnostics company specializing in the early detection of cancer, today announced the appointment of Dr. D. Kim Turgeon of the University of Michigan Health at its Medical Advisory Board (MAB).
MAB is supporting the company’s upcoming U.S. pivotal trial for ColoAlert, its highly effective and easy-to-use detection test for colorectal cancer (CRC), and is helping Mainz evaluate ColoAlert’s potential to treat other oncology indications while improving Mainz’s product pipeline candidates.
Esteemed clinical professor at the University of Michigan Health and translational clinical researcher, Dr. Turgeon was co-lead of BETRNet, a multidisciplinary, multi-institutional collaboration co-sponsored by the Division of Cancer Prevention of the National Cancer Institute (NCI). and Division of Cancer Biology (2011-2022), co-I of the Network for Translational Research (NTR) (2008-2013) and co-lead of the Great Lakes-New England Clinical Epidemiology and Validation Center of the NCI Detection Research Network early (2000-2015). Dr. Turgeon has an established and extensive record in protocol development, protocol implementation, subject recruitment, subject retention, and in-depth clinical data management skills and has provided hands-on gastrointestinal knowledge. -Clinical enterology and endoscopy to support clinical research efforts. She received her medical degree from the University of Rochester in New York and completed her residency in internal medicine at the University of Rochester’s Strong Memorial Hospital. His special research interests include colon cancer, chemoprevention and drug metabolism.
“We are excited to assemble a MAB that will bring together a highly distinguished group of multidisciplinary experts such as Dr. Turgeon,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “Having access to a wealth of expertise in gastroenterology, clinical research and diagnostics as we establish our pivotal trial in the United States, will ensure that the process is as efficient and transparent as possible and that ColoAlert can be made accessible. to more people around the world and help turn the tide against the devastating effects of CRC.
Mainz announced in February 2022 that the US pivotal clinical trial pre-submission of ColoAlert had been accepted for review by the US Food & Drug Administration (FDA), and in March received favorable comments on the filing pre-submission outlining the potential clinical trial design for ColoAlert. Mainz will continue to bring together gastroenterology and pathology experts to provide ongoing guidance throughout pre-marketing activities, including FDA submission. Their input will ensure that clinical study endpoint definitions are aligned with current standards and practice, and that a comprehensive adjudication plan is executed to ensure endpoints are ranked accordingly. In addition, MAB will play an active role in analyzing new tests being considered internally for development and in evaluating licensing and M&A opportunities.
Mainz currently markets ColoAlert through its unique business model of partnering with third-party labs to process test kits versus traditional single-facility operating methodology. The company is also leading ColoFuture, an international clinical study evaluating the potential for incorporating a portfolio of novel licensed mRNA biomarkers into the product, which have already demonstrated the unique ability to identify curable precancerous colon polyps, as well as than treatable CRC at an early stage. (Herring et al 2021). ColoFuture is evaluating the effectiveness of these biomarkers to improve the technical profile of ColoAlert to expand its ability to include the identification of advanced adenomas (AA), a type of precancerous polyp often attributed to CRC, while increasing sensitivity rates and diagnostic specificity of ColoAlert. The results of the study will ultimately impact the configuration of ColoAlert before the start of the pivotal US study which is expected to begin in 2023.
ColoAlert detects colorectal cancer (CRC) via a simple to administer test with almost as high sensitivity and specificity as invasive colonoscopy*. The test uses proprietary methods to analyze cellular DNA for specific tumor markers combined with the Fecal Immunochemical Test (FIT) and is designed to detect tumor DNA and cases of CRC in their early stages. The product is CE-IVDR marked (meets EU safety, health and environmental requirements). The product is commercially available in selected European Union countries and the United Arab Emirates. Mainz Biomed currently distributes ColoAlert through a number of clinical affiliates. Once approved in the United States, the company’s business strategy is to establish scalable distribution through a collaborative partnership program with regional and national laboratory service providers across the country.
*Dollinger MM et al. (2018)
About colorectal cancer
Colorectal cancer (CRC) is the second deadliest cancer in the United States and Europe, but also the most preventable with early detection offering survival rates over 90%. Annual testing costs per patient are minimal, especially compared to late-stage CRC treatments that cost patients an average of $38,469 per year. The American Cancer Society estimated that in 2021 there were approximately 149,500 new cases of colon and rectal cancer in the United States, 52,980 of which resulted in death. Recent FDA rulings suggest that screening with stool DNA tests such as ColoAlert in the US should be done once every three years starting at age 45. years. Appropriately testing these US-based 50+ populations every three years, as prescribed, equates to a US market opportunity of approximately $3.7 billion per year.
About Mainz Biomed NV
Mainz Biomed develops market-ready molecular genetic diagnostic solutions for life-threatening diseases. The Company’s lead product is ColoAlert, an accurate, non-invasive and easy-to-use early detection diagnostic test for colorectal cancer. ColoAlert is currently marketed across Europe and the United Arab Emirates with plans to begin its pivotal FDA clinical study in 2022 for US regulatory approval. Mainz Biomed’s pipeline of product candidates includes PancAlert, an early detection test for pancreatic cancer based on real-time, multiplex polymerase chain reaction (PCR)-based detection of molecular genetic biomarkers in stool specimens, and GenoStick technology, a platform under development to detect pathogens on a molecular genetic basis.
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