Mainz Biomed N.V. (“Mainz Biomed” or the “Company”), a molecular genetics diagnostics company specializing in the early detection of cancer, announced 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.
Mainz Biomed develops market-ready molecular genetic diagnostic solutions for life-threatening conditions. The Company’s flagship product is ColoAlert, an accurate, non-invasive, and easy-to-use early detection diagnostic test for colorectal cancer.