Mainz Biomed’s colorectal cancer test receives Swiss regulatory approval

BERKELEY, Calif. and MAINZ, Germany - Mainz Biomed N.V. (NASDAQ:MYNZ), a molecular diagnostics company with a market capitalization of $5.06 million and gross profit margins of 64%, announced Wednesday that its non-invasive colorectal cancer screening test, ColoAlert, has received regulatory approval from Swissmedic, Switzerland’s authority for medicinal products and medical devices. According to InvestingPro data, the company maintains a healthy balance sheet with more cash than debt, though it’s currently in a growth phase with negative earnings.

The approval allows for the distribution of ColoAlert in the Swiss market, where colorectal cancer screening programs primarily target the approximately 2.8 million individuals between ages 50 and 74, representing about 31.4% of Switzerland’s population. This market expansion opportunity comes as the company reported annual revenue of $890,000, with InvestingPro analysts projecting 24% revenue growth for the next fiscal year.

This regulatory milestone follows Mainz Biomed’s previously announced partnership with Swiss laboratory labor team w ag earlier this year. The company stated that ColoAlert will be made available through the partner laboratory’s diagnostic service offering.

"We are pleased to receive regulatory approval in Switzerland," said Guido Baechler, CEO of Mainz Biomed, in the press release statement.

Current colorectal cancer screening options in Switzerland include biennial Fecal Immunochemical Tests or colonoscopies every 10 years. Despite having over 13 screening programs nationwide, participation rates remain below 50%, according to the company.

ColoAlert is designed to detect colorectal cancer tumor DNA and other biomarkers in stool samples. The test is currently marketed in select European countries and the United Arab Emirates.

Mainz Biomed is also conducting a pivotal FDA clinical study for U.S. regulatory approval of ColoAlert. The company focuses on developing molecular genetic diagnostic solutions through decentralized partnerships with laboratories and regional healthcare providers.

The information in this article is based on a press release from Mainz Biomed. Based on InvestingPro analysis, the company appears undervalued relative to its Fair Value, despite facing near-term profitability challenges. InvestingPro subscribers have access to 10+ additional investment insights about MYNZ, including detailed financial health scores and growth projections.

In other recent news, Mainz Biomed announced plans to provide an interim update on its eAArly DETECT 2 feasibility study by the end of summer 2025. This study is focused on evaluating the company’s next-generation colorectal cancer screening test. The aim is to enhance early detection and prevention of the disease. The study is currently assessing the integration of proprietary mRNA biomarkers, an AI-developed algorithm, and a fecal immunochemical test across a population of approximately 2,000 average-risk patients. This initiative seeks to validate the promising results from previous studies and support the shift from colorectal cancer screening to prevention. These developments are part of Mainz Biomed’s ongoing efforts to advance its diagnostic capabilities.

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