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Mainz Biomed Establishes Partnership with Precision for Medicine to Support ColoAlert’s U.S. Regulatory and Commercial Strategy
BERKELEY, Calif. and MAINZ, Germany, Nov. 30, 2021 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics
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[{"type":"text","content":"BERKELEY, Calif. and MAINZ, Germany, Nov. 30, 2021 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostics company specializing in the early detection of cancer, announced today the Company has engaged Precision for Medicine, a leading global Clinical Research Organization, to provide U.S. regulatory and reimbursement advisory support for ColoAlert, Mainz’s highly efficacious and easy-to-use diagnostic test for colorectal cancer. “As an emerging commercial stage company with a portfolio of non-invasive, highly efficacious diagnostics for detection of early-stage cancer indications in development, we are mindful of the need to operate a streamlined corporate and clinical organization,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “I’m extremely pleased to partner with Precision for Medicine as they provide premier and comprehensive solutions that can help ensure ColoAlert is well positioned to achieve FDA regulatory approval, and acceptance by the Centers for Medicare and Medicaid (CMS) for reimbursement, which is of course, essential for gaining commercial traction.” Precision for Medicine will work with Mainz’s management team to develop and implement a U.S. focused regulatory and market access strategy for ColoAlert, the Company’s unique, life-saving early detection test for colorectal cancer (CRC). This will include assistance in drafting ColoAlert’s clinical development plan to ensure the trial design is cost-effective, robust, and efficient. Inherent to this exercise will be the integration of CMS guidelines, utilizing currently marketed CRC screening tests as benchmarks to provide ColoAlert with an optimal product profile for regulatory approval and success in the marketplace. Along the way, Precision for Medicine will advise Mainz throughout its interaction with the FDA’s pre-submission protocol. About ColoAlertColoAlert detects colorectal cancer (CRC) via a simple-to-administer test with a sensitivity and specificity nearly as high as the invasive colonoscopy*. The test utilizes proprietary methods to analyze cell DNA for specific tumor markers combined with the fecal immunochemistry test (FIT) and is designed to detect tumor DNA and CRC cases in their earliest stages. The product is CE-IVD marked (complying with EU safety, health and e...