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Mainz Biomed Partners with Trusted Health Advisors to Support U.S. Go-To-Market Strategy for Next Generation Early Colorectal Cancer Diagnostic
BERKELEY, Calif. and MAINZ, Germany, March 05, 2024 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a leader in molecular genetics diagnostic solutions for early cancer detection, announced today a partnership with Trusted Health Advisors (THA), a market leader in supporting the U.S. launches and management of commercial programs for diagnostic products. Mainz Biomed is in late-stage clinical development of a highly accurate and easy-to-use nucleic acid-based detection test for colorectal cancer (CRC) screening diagnostics that it intends to distribute, if approved, via the Company’s unique business model of marketing products via partnerships with third-party laboratories. In the U.S., Mainz Biomed is in final regulatory planning stages of ReconAAsense clinical trial to seek Premarket Approval (PMA) for its next generation diagnostic test. The Company currently commercializes its first-generation test in Europe and in select international territories through its flagship product ColoAlert® via partnerships with third-party laboratories. “As we make the final preparations to commence patient enrollment in the ReconAAsense trial and given the potentially transformative role the test will have on the market if approved, we are excited by the opportunity to be in a position to advance our U.S. go-to-market strategy for our innovative approach in CRC screening,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “Through our partnership with THA, we plan to expedite and enhance the deployment of our differentiated commercial strategy to enable an efficient and impactful transition to the marketplace for the product which if approved, we anticipate will occur in 2026. We look forward to working with Drs. Wohlgemuth, Tabibiazar and the entire THA team.” “Mainz Biomed’s early data in accurate detection of Advanced Adenoma has the potential to transform colon cancer screening” said Dr. Jay Wohlgemuth, Managing Partner at THA. “Detecting AA lesions allows for early intervention and significantly increases the chance of successful treatment and survival. Furthermore, early detection and treatment of AA is more cost-effective than treating cancer.” “Mainz Biomed’s easy-to-use kit as well as their differentiated business model to commercialize their diagnostic test via partnerships with third-party laboratories versus the traditional methodology of operating a single facility, could dramatically increase patient access to the test and help improve patient outcomes,” said Dr. Ray Tabibiazar, Managing Partner at THA, “the THA team is excited to support Mainz Biomed in its efforts to advance this promising pre-cancer test for patients in need.” The partnership with THA will be led by Drs. Jay Wohlgemuth and Ray Tabibiazar, Managing Partners of the firm. Dr. Wohlgemuth brings to the project a prolific development and commercial background in healthcare innovation having most recently served in multiple senior executive roles at Quest Diagnostics including, Chief Medical Officer, Chief Scientific Officer and Senior Vice President. In addition, Dr. Wohlgemuth was a co-founder, Chief Medical Officer and Vice President of R&D for CareDx, a leader in testing for transplant patients for which he was awarded Technology Pioneer 2005 at the World Economic Forum in Davos. Dr. Tabibiazar is a veteran CEO, entrepreneur and investor in the biotechnology and diagnostics space. The THA team brings extensive experience and capabilities, from R&D through commercialization, across the diagnostics industry, including lab diagnostics, in vitro diagnostics, medical devices, and population health management. To learn more about THA, please visit https://www.trstedhealthadvisors.us ReconAAsense (ClinicalTrials.gov Identifier: NCT05636085) is Mainz Biomed’s pivotal FDA PMA clinical trial evaluating a next generation CRC screening test which will integrate the Company’s portfolio of novel gene expression (mRNA) biomarkers. Recently (Q4 2023), Mainz Biomed announced groundbreaking results from ColoFuture (international) and eAArly DETECT (U.S.) clinical studies evaluating these biomarkers whereby ColoFuture reported sensitivity for CRC of 94% with specificity of 97% and advanced adenoma (AA) sensitivity of 80% and eAArly DETECT reported sensitivity for colorectal cancer of 97% with a specificity of 97% and a sensitivity for advanced adenoma of 82%. Mainz Biomed is in the process of selecting the biomarkers for inclusion into ReconAAsense of which the results will form the basis of the data package for review by the U.S. Food and Drug Administration (FDA) to achieve marketing authorization. It will include approximately 15,000 subjects from 150 sites across the U.S. The study’s primary objectives include calculating sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) in average-risk subjects for CRC and AA. Given the integration of Mainz Biomed’s portfolio of novel gene expression (mRNA) biomarkers into ReconAAsense, if the trial produces positive results, this next iteration of Mainz Biomed’s CRC test will be positioned as one of the most robust and accurate at-home diagnostic screening solutions on the market as it will not only detect cancerous polyps with a high degree of accuracy but has the potential to prevent CRC through early detection of precancerous adenomas. Please visit Mainz Biomed’s official website for investors at mainzbiomed.com/investors/ for more information. About ColoAlert® About Colorectal Cancer About Mainz Biomed N.V. 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