Laboratory Gazette Briefs

Mainz Biomed & Dante Labs Announces Partnership for ColoAlert Commercialization in Europe and United Arab Emirates (UAE)

• Dante Labs is a world leader in genomics and precision medicine
জ Mainz exclusively focuses on the development of next-generation diagnostics for early detection of cancer.

Berkeley, Calif. And Mainz, Germany and New York, May 20, 2022 (Globe Newswire) – Mainz Biomed NV (NASDAQ: MYNZ) (“Mainz” or “Company”), a molecular genetic diagnostic company specializing in cancer detection, and Dante. Labs, a world leader in genomics and precision medicine, today announced a partnership to commercialize ColoAlert in Italy and the United Arab Emirates (UAE). ColoAlert is Mainz’s flagship colorectal cancer (CRC) home test that is highly effective and easy to use.

Dante Labs is the world leader in genome sequencing. The company has a marketing and product development franchise that focuses on providing personalized preventive healthcare solutions. It uses its powerful database and proprietary software platform to deliver next-generation diagnostic tools directly to customers and healthcare professionals. Operating state-of-the-art genomic sequencing labs in multiple international regions and operating a powerful e-commerce platform is part of the Dante Labs business model.

“As a young company aiming to bring to market important diagnostic equipment to help treat and prevent cancer, it is an absolute pleasure to partner with an industry leader like Dante Labs,” said Guido Bechler, CEO of Mainz Biomed. “Unlike traditional single-site operating systems, our separate business plan for partnering with third-party labs to process test kits is by partnering with like-minded companies, such as Dante Labs, which have the same passion for diagnostic development. Test and think forward marketing strategies. A

The partnership will first launch ColoAlert in Italy and the UAE using various commercial channels set up by Dante. Samples will be processed primarily at Mainz’s in-house site, then Dante will purchase a CE-IVD Polymerase Chain Reaction (PCR) test kit from Mainz and transfer all test processing to a fully automated genomic sequencing lab. Dante-owned Italy (Europe) and Dubai (UAE) to provide local services and support.

Dante Labs President and CEO Andrea Riposati commented, “We are thrilled to have the opportunity to align with Mainz and represent ColoAlert in this first market. “Products and companies align with our goal of developing and marketing leading preventive health solutions and using innovative channels to make innovative trials available to more patients around the world. With the launch of our advanced e-commerce platform for advanced diagnostics, ColoAlert is an incredible product when it comes to delivering more personalized medicines. A

ColoAlert is currently marketed across Europe, and the partnership with Dante Labs marks the initial launch of the experiment in the Middle East. Mainz will continue to develop business and R&D partnerships with companies at the forefront of medical screening, with a special focus on stool diagnosis.

About ColoAlert
ColoAlert detects colorectal cancer (CRC) through a simple examination with high sensitivity and specificity, such as invasive colonoscopy *. The test uses proprietary methods to analyze cellular DNA for specific tumor markers related to the fecal immunochemical test (FIT). The test is designed to detect tumor DNA and CRC in the early stages. The product is CE-IVD marked (meets EU safety, health and environmental requirements) and changes to IVDR compliance. This product is marketed in several countries of the European Union. Mainz Biomed currently distributes ColoAlert through a number of clinical partners. Once approved in the United States, the company’s business strategy is to establish measurable 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 most deadly cancer in the United States and Europe, but the most preventable with early detection provides a survival rate of over 90%. The cost of annual testing per patient is minimal, especially compared to the final stage of CRC treatment which costs patients an average of $ 38,469 per year. The American Cancer Society estimates that by 2021 there will be approximately 149,500 new cases of colon and rectal cancer in the United States, resulting in 52,980 deaths. Recent FDA rulings suggest that stool DNA screening, like ColoAlert, should be performed once every three years in the United States, starting at age 45. Currently, there are 112 million Americans aged 50 and over, with a total expected to rise to 157 million in 10 years. Properly examining this 50+ population living in the United States every three years, as determined, equals about $ 3.7 billion in U.S. market opportunities each year.

About Mainz Biomed NV
Mainz Biomed develops market-ready molecular genetic diagnostic solutions for life-threatening diseases. The company’s flagship product is ColoAlert, an accurate, non-invasive and easy-to-use colorectal cancer early detection diagnostic test. ColoAlert is currently being marketed across Europe with an FDA clinical study and submission process in the first half of 2022 for U.S. regulatory approval. Mainz Biomed’s product portfolio of candidates includes PancAlert, a real-time based pancreatic cancer early detection test, multiplex polymerase chain reaction (PCR) – a molecular genetic biomarker detection in stool-based stool samples, and genotyping technology. Pathogens based on molecular genetics.
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About Dante Labs
Dante Labs is a global genomics information company created and commercialized a new class of transformative health and longevity applications based on genome sequencing and artificial intelligence. The company uses its platform to improve patient outcomes from diagnosis to therapy, including one of the largest private genome databases with research consent, a proprietary software platform designed to publish power scale genomic data and a patent process for genomics. Enables the industrial approach. Sequencing

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