Quest Diagnostics will support Mainz Biomed’s ReconAAsense FDA study and may commercialize the test kit if the FDA approves it.

BERKELEY, Calif. and MAINZ, Germany, Dec. 19, 2024 — Mainz Biomed N.V. (NASDAQ:MYNZ), a molecular genetics diagnostics company focused on early cancer detection, today announced a collaboration with Quest Diagnostics (NYSE:DGX), a leading diagnostic services provider, to support the commercialization of Mainz Biomed’s next-generation colorectal cancer screening test.

Mainz Biomed’s stool-based ColoAlert test detects colorectal cancer tumor DNA to help identify the disease in its early stages. Using polymerase chain reaction (PCR) technology, it analyzes a small DNA sample from a stool specimen to identify genetic mutations potentially indicative of cancer. Preliminary data suggests the ColoAlert test exhibits promising sensitivity and specificity in detecting colorectal cancer, including advanced adenomas.

Quest will provide clinical trial laboratory services for Mainz Biomed’s ReconAAsense study, a prospective clinical trial involving approximately 15,000 participants at 150 sites across the US. This study will generate data to support FDA validation of the NextGen test. Mainz Biomed will grant Quest the option to secure semi-exclusive rights to provide testing services using the test kit for an 18-month period, contingent upon FDA approval.

Colorectal cancer (CRC) is the third most prevalent cancer globally, with over 1.9 million new cases reported in 2020 (World Cancer Research Fund). The US Preventive Services Task Force recommends stool DNA-FIT (sDNA-FIT) screening every one to three years starting at age 45. Approximately one-third of US residents aged 50-75 have never undergone colon cancer screening, representing a significant market opportunity exceeding $4 billion in the US. Alternative screening methods like sDNA-FIT could address this unmet need.

“We are pleased to partner with Quest Diagnostics,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “Quest’s expertise in cancer diagnostics and ability to scale innovations makes them an ideal partner. Their support will advance the commercial development of our ColoAlert test, improving access to quality screening for more patients.”

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About Mainz Biomed NV
Mainz Biomed develops market-ready molecular genetic diagnostic solutions for life-threatening diseases. The Company’s flagship product, ColoAlert®, is an accurate, non-invasive, and user-friendly early detection test for colorectal cancer, currently marketed in Europe and the United Arab Emirates. A pivotal FDA clinical trial is underway for US regulatory approval. Mainz Biomed’s pipeline also includes PancAlert, an early-stage pancreatic cancer screening test using real-time PCR multiplex detection of molecular-genetic biomarkers in stool samples. For more information, visit or follow us on , and .

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Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are subject to risks and uncertainties, and actual results may differ materially. Factors that could cause actual results to differ include: failure to meet development targets, changes in laws or regulations, the impact of the COVID-19 pandemic, and other risks detailed in the Company’s SEC filings, including its Form 20-F filed April 9, 2024. These filings are available at www.sec.gov. Any forward-looking statement speaks only as of its date, and Mainz Biomed disclaims any obligation to update these statements.

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