DGAP-News: Mainz Biomed and Dante Genomics Announce Full Commercial Availability of ColoAlert in Italy and the United Arab Emirates

Mainz Biomed and Dante Genomics Announce Full Commercial Availability of ColoAlert in Italy and the United Arab Emirates

 – ColoAlert to be marketed through Dante’s extensive database and sold via its region-specific, ecommerce websites –

BERKELEY, Calif. and MAINZ, Germany and NEW YORK, August 16, 2022 -- Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz'' or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, and Dante Genomics, a global leader in genomics and precision medicine, announced today the formal commencement of ColoAlert’s consumer commercial program 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) currently being commercialized across Europe and select international markets. With the ColoAlert test CE-IVD certified and patient collection kit CE marked to the latest IVDR requirements, ColoAlert will now be marketed through Dante’s extensive database and sold via Dante’s, region-specific, ecommerce websites.

 “This is an important milestone for the company as it expands our global footprint while providing access to those who can benefit from our cutting-edge early detection CRC test in these additional major international territories,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “Dante has been an exceptional partner, and we look forward to continue working closely with them as they actively market and sell ColoAlert and also as they transition from processing samples at Mainz’s in-house facility, to their own wholly-owned automated genomic sequencing laboratories in Italy (Europe) and Dubai (UAE) where they’ll offer localized service and support.”

Dante Genomics is a global leader in whole genome sequencing and holds an existing database of tens of thousands of whole genomes. The company has a product development and commercial franchise focused on providing personalized preventive healthcare solutions. It achieves this by leveraging its robust databases and proprietary software platform to offer next-generation diagnostic tools direct to consumers and healthcare professionals.

“From our perspective, ColoAlert represents the first true step toward personalized medicine in colorectal cancer, and we are excited to leverage our expertise in genomic data to partner with Mainz in commercializing this important diagnostic tool,” said Andrea Riposati, Chief Executive Officer of Dante Genomics. “Through our partnership with Mainz, we will drive more informed healthcare decisions and empower patients with their genomic data.”

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 Europe 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.

*Dollinger MM et al. (2018)

About Colorectal Cancer

Colorectal cancer (CRC) is the second most lethal cancer in the U.S. and Europe, but also the most preventable with early detection providing survival rates above 90%. Annual testing costs per patient are minimal, especially when compared to late-stage treatments of CRC 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 colon and rectal cancer in the U.S. with 52,980 resulting in death.  Recent FDA decisions suggest that screening with stool DNA tests such as ColoAlert in the US should be conducted once every three years starting at age 45. Currently there are 112 million Americans aged 50+, a total that is expected to increase to 157 million within 10 years. Appropriately testing these US-based 50+ populations every three years as prescribed equates to a US market opportunity of approximately $3.7 Billion per year.

About Mainz Biomed N.V.

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. ColoAlert is currently marketed across Europe with FDA clinical study and submission process intended to be launched in the first half of 2022 for U.S. regulatory approval. Mainz Biomed’s product candidate portfolio includes PancAlert, an early-stage pancreatic cancer screening test based on Real-Time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in stool samples, and the GenoStick technology, a platform being developed to detect pathogens on a molecular genetic basis.

For more information please visit www.mainzbiomed.com

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About Dante Genomics

Dante Genomics is a global genomic information company building and commercializing a new class of transformative health and longevity applications based on whole genome sequencing and AI. The Company uses its platform to deliver better patient outcomes from diagnostics to therapeutics with assets including one of the largest private genome databases with research consent, proprietary software designed to unleash the power of genomic data at scale and proprietary processes which enable an industrial approach to genomic sequencing.

Forward-Looking Statements

Certain statements made in this press release are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate”, “believe”, “expect”, “estimate”, “plan”, “outlook”, and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements reflect the current analysis of existing information and are subject to various risks and uncertainties. As a result, caution must be exercised in relying on forward-looking statements. Due to known and unknown risks, actual results may differ materially from the Company’s expectations or projections. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: (i) the failure to meet projected development and related targets; (ii) changes in applicable laws or regulations; (iii) the effect of the COVID-19 pandemic on the Company and its current or intended markets; and (iv) other risks and uncertainties described herein, as well as those risks and uncertainties discussed from time to time in other reports and other public filings with the Securities and Exchange Commission (the “SEC”) by the Company. Additional information concerning these and other factors that may impact the Company’s expectations and projections can be found in its initial filings with the SEC, including its Prospectus filed on October 12, 2021 and amended on October 25, 2021 and November 1, 2021 as well as the Prospectus filed on January 21, 2022. The Company’s SEC filings are available publicly on the SEC’s website at www.sec.gov. Any forward-looking statement made by us in this press release is based only on information currently available to Mainz Biomed and speaks only as of the date on which it is made. Mainz Biomed undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, except as required by law.