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Mainz Biomed & Dante Labs Announce Partnership for the Commercialization of ColoAlert in Europe and the United Arab Emirates

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Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer and Dante Labs, a global leader in genomics and precision medicine, announced today a partnership for the commercialization of ColoAlert in Italy and the United Arab Emirates (UAE).

ColoAlert is Mainz’s flagship product, a highly efficacious and easy-to-use at-home detection test for colorectal cancer (CRC).

Dante Labs is a global leader in genome sequencing with a product development and commercial franchise focused on providing personalized preventive healthcare solutions by leveraging its robust databases and proprietary software platform to offer next-generation diagnostic tools direct to consumers and healthcare professionals. Inherent to Dante Lab’s business model is managing state-of-the-art genomic sequencing laboratories in multiple international regions, and operating a robust e-commerce platform.

“As a young company with the goal of bringing to market important diagnostic tools to help treat and prevent cancer indications, it’s an absolute pleasure to partner with an industry leader such as Dante Labs,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “Our differentiated commercial plan of partnering with third-party laboratories for test kit processing versus the traditional methodology of operating a single facility requires alliances with like-minded companies such as Dante Labs, who share our passion for forward-thinking diagnostic test development and marketing strategies.”

The partnership will first launch ColoAlert in Italy and UAE using Dante’s various established commercial channels. Samples will initially be processed at Mainz’s in-house facility and then Dante will purchase Mainz’s CE-IVD polymerase chain reaction (PCR) assay kits and transition all test processing to Dante’s wholly-owned automated genomic sequencing laboratories in Italy (Europe) and Dubai (UAE) to offer localized service and support.

“We are excited by the opportunity to align with Mainz and represent ColoAlert in these initial markets,” commented Andrea Riposati, Chief Executive Officer of Dante Labs. “Both the product and the Company mirror our mission to develop and market top-tier preventive health solutions and use new channels to make innovative tests available to more patients around the world. With the launch of our enhanced ecommerce platforms for advanced diagnostics, ColoAlert is an amazing product to deliver more personalized medicine.”

ColoAlert is currently marketed across Europe, and the partnership with Dante Labs marks the test’s initial launch in the Middle East. Mainz will continue to develop commercial and R&D partnerships with companies that lead the field of health screening with a particular focus on stool diagnostics.

*Dollinger MM et al. (2018)

About ColoAlert: ColoAlert 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 immunochemical 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 environmental requirements) and is transitioning to compliance with IVDR. The product is commercially available in a selection of countries in the European Union. Mainz Biomed currently distributes ColoAlert through a number of clinical affiliates. Once approved in the U.S., the Company’s commercial strategy is to establish scalable distribution through a collaborative partner program with regional and national laboratory service providers across the country.

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