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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 or follow us on LinkedInTwitter and Facebook.

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