Mainz Biomed Announces Live Launch of ColoAlert® with testDNA Laboratory in Poland

Strategic Partnership Aims to Revolutionize Cancer Screening and Enhance Healthcare Outcomes, Bringing Innovative Genetic Testing Solutions to Individuals Across Poland

BERKELEY, US – MAINZ, Germany – August 22, 2023 — Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”) , a molecular genetics diagnostic company specializing in the early detection of cancer, announces the commercial launch of ColoAlert® in Poland, made possible through a strategic collaboration with testDNA Sp. z o. o. Sp. K (“testDNA”). The partnership marks another significant step forward in providing new and innovative testing options to underserved populations in the battle against colorectal cancer (“CRC”).

ColoAlert®, Mainz Biomed's flagship product is a user-friendly and highly effective at-home screening test able to help meaningfully address the pressing global challenge of early colorectal cancer detection. The strategic alliance with testDNA aims to extend the reach of this transformative technology, providing improved access to screening tools that come with the potential to save countless lives across Poland.

Operating since 2003, testDNA is a national leader in the field of DNA-based testing services. As an accredited research laboratory sanctioned by the Polish Center for Accreditation, the laboratory is headquartered in Katowice, Poland, and boasts an expansive network of over 300 collection points throughout the country. With a comprehensive portfolio, testDNA is renowned for delivering state-of-the-art genetic-based testing solutions tailored to individual needs.

The urgency for alternative CRC screening options is underscored by data from the World Cancer Research Fund International which ranked Poland 7th (seventh) in the world for the highest mortality rate. With over 21 million people aged over 40, the market opportunity for ColoAlert® is significant, especially as there has been a low level of national participation in CRC screening which traditionally has been colonoscopies. In the recently published NordICC study in the New England Journal of Medicine, only 33% of those invited to participate in colonoscopy screening actually took part. This highlights the need to have alternative screening options that are less invasive and easier to perform at home.

Darin Leigh, Chief Commercial Officer of Mainz Biomed, emphasized the pivotal role of this collaboration: "Partnering with testDNA to initiate our entry into the Polish market signifies another critical step in our mission to extend the reach of ColoAlert® to individuals at risk of colorectal cancer. Together, we are well positioned to help transform and improve the current cancer screening options in Poland and provide timely interventions that have the potential to save lives."

About ColoAlert®
ColoAlert®, Mainz Biomed’s flagship product, delivers high sensitivity and specificity in a user-friendly, at-home colorectal cancer (CRC) screening kit. This non-invasive test can be indicative of tumors as determined by analyzing tumor DNA, offering better early detection than fecal occult blood tests (FOBT). Based on PCR-technology, ColoAlert® detects more cases of colorectal cancer than other stool tests and allows for an earlier diagnosis (Gies et al., 2018). The product is commercially available in select EU countries through a network of leading independent laboratories, corporate health programs and via direct sales. To receive marketing approval in the US, ColoAlert® will be evaluated in the FDA-registration trial ‘ReconAAsense.’ Once approved in the US, 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.

About Colorectal Cancer
Colorectal cancer (CRC) is the third most common cancer globally, with more than 1.9 million new cases reported in 2020, according to World Cancer Research Fund International. The US Preventive Services Task Force recommends that screening with stool DNA tests such as ColoAlert® should be conducted once every three years starting at age 45. Each year in the US, 16.6 million colonoscopies are performed. However, roughly one-third of US residents aged 50-75 have never been screened for colon cancer. This gap in screening represents a $4.0B+ total market opportunity in the US.

About Mainz Biomed NV
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 based on real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in stool samples. ColoAlert® is currently marketed across Europe. The Company is running a pivotal FDA clinical study for US regulatory approval. Mainz Biomed’s product candidate portfolio also includes PancAlert, an early-stage pancreatic cancer screening test. To learn more, visit mainzbiomed.com or follow us on LinkedIn, Twitter and Facebook.
 

For media inquiries, please contact [email protected]

In Europe:

MC Services AG
Anne Hennecke/Caroline Bergmann
+49 211 529252 20
[email protected]
 

In the U.S.:

Josh Stanbury
+1 416 628 7441
[email protected]

For investor inquiries, please contact [email protected]

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 annual report on Form 20-F filed on April 7, 2023. The Company’s SEC filings are available publicly on the SEC’s website at 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.