Laboratory journal summaries

2022-05-30
Mainz Biomed & Dante Labs announces partnership to market ColoAlert in Europe and the United Arab Emirates (UAE)

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

Berkeley, CA and Mainz, Germany and New York, May 20, 2022 (GLOBE NEWSWIRE) – Mainz Biomed NV (NASDAQ: MYNZ) (“Mainz” or “the Company”), a molecular genetics diagnostics company specializing in cancer detection, and Dante Labs, a global leader in Genomics and Precision Medicine, today announced a partnership to market ColoAlert in Italy and the United Arab Emirates. ColoAlert is Mainz’s leading home test for colorectal cancer (CRC) and is highly effective and easy to use.

Dante Labs is a global leader in genome sequencing. The company has a marketing and product development franchise focused on providing customized preventive healthcare solutions. It leverages powerful databases and its proprietary software platform to deliver next generation diagnostic tools directly to consumers and healthcare professionals. Running state-of-the-art genetic sequencing laboratories in multiple international regions and operating a robust e-commerce platform is inherent to Dante Labs’ business model.

Guido Baechler, CEO of Mainz Biomed, commented, “As a young company with the goal of bringing important diagnostic tools to market to aid in the treatment and prevention of cancer conditions, it is my absolute pleasure to partner with an industry leader like Dante Labs.” . “Compared to the traditional single-site operating methodology, our differentiated business plan for partnering with third-party laboratories to process test suites is through alliances with like-minded companies, such as Dante Labs, that have the same passion for developing diagnostic tests and future marketing strategies.”

This partnership will first launch ColoAlert in Italy and the United Arab Emirates using the various commercial channels that Dante has established. Samples will be initially processed at the in-house Mainz site, then Dante will purchase CE-IVD Polymerase Chain Reaction (PCR) Test Kits from Mainz and transfer all testing processes to fully automated genetic sequencing laboratories. Dante is owned in Italy (Europe) and Dubai (UAE) to provide local service and support.

“We are excited about the opportunity to align with Mainz and represent ColoAlert in these first markets,” Andrea Riposati, President and CEO of Dante Labs commented. The product and company are aligned with our mission to develop and market leading-edge preventive health solutions and use new channels to make innovative testing available to more patients around the world. With the launch of our enhanced e-commerce platforms for advanced diagnostics, ColoAlert is a great product when it comes to offering more personalized medication. »

ColoAlert is currently marketed throughout Europe, and the partnership with Dante Labs marks the initial test launch in the Middle East. Mainz will continue to develop business and research and development partnerships with companies that are at the fore in the field of medical screening, with a particular focus on stool diagnostics.

About ColoAlert
ColoAlert detects colorectal cancer (CRC) by performing a simple test with nearly as high a sensitivity and specificity as an invasive colonoscopy*. The test uses proprietary methods to analyze cellular DNA for specific tumor markers associated with the stool immunohistochemical test (FIT). The test is designed to detect tumor DNA and CRC cases in their early stages. The product is CE-IVD marked (meets EU safety, health and environmental requirements) and is in transition to be IVDR compliant. This product is marketed in select European Union countries. Mainz Biomed currently distributes ColoAlert through a number of clinical branches. Once approved in the United States, the company’s business strategy is to create scalable 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 deadliest cancer in the United States and Europe, but it is also the most preventable type of cancer with early detection providing survival rates of over 90%. Annual testing costs per patient are minimal, especially compared to late-stage CRC treatments which cost patients an average of $38,469 per year. The American Cancer Society estimated that in 2021 there were approximately 149,500 new cases of colorectal cancer in the United States, with 52,980 cases resulting in death. Recent FDA rulings state that a stool DNA test like ColoAlert in the US should be done once every three years starting at age 45. There are currently 112 million Americans aged 50 and over, and the total is expected to rise to 157 million within 10 years. Proper testing for those people over 50 who live in the United States every three years, as described, equates to a US market opportunity of approximately $3.7 billion annually.

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 diagnostic test for the early detection of colorectal cancer. ColoAlert is currently marketed throughout Europe with a clinical study from the Food and Drug Administration and the application process is expected to begin in the first half of 2022 for US regulatory approval. Mainz Biomed’s suite of candidate products includes PancAlert, an early detection test for pancreatic cancer based on multiplex polymerase chain reaction (PCR)-based detection of molecular biomarkers in stool samples, and GenoStick technology, a platform under development for the detection of pathogens on Molecular genetic basis.
For more information, please visit www.mainzbiomed.com

About Dante Laboratories
Dante Labs is a global genomics information company that builds and commercializes 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 treatment, with assets including one of the largest research consent genome databases, a proprietary software platform designed to unleash power scale genomic data and patented processes that enable an industrial approach to genome sequencing.

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