Mainz Biomed's ColoAlert Receives Swiss Regulatory Approval for Colorectal Cancer Screening

Mainz Biomed's ColoAlert, a non-invasive colorectal cancer screening test, has received Swiss regulatory approval for distribution by Swissmedic. This follows a partnership with local laboratory labor team w ag earlier this year. ColoAlert is now authorized for use in the Swiss market and will be available through the partner laboratory's diagnostic service offering.

Mainz Biomed N.V. (NASDAQ: MYNZ), a molecular genetics diagnostic company, has received regulatory approval from Swissmedic for its non-invasive colorectal cancer (CRC) screening test, ColoAlert®. This approval follows a strategic partnership with a local Swiss laboratory, labor team w ag, earlier this year [1].

ColoAlert® is designed to detect CRC tumor DNA and other biomarkers in stool samples with high sensitivity. It is currently marketed in select European countries and is now authorized for use in Switzerland, where it will be made available through the partner laboratory’s diagnostic service offering [2].

The Swiss market represents a significant opportunity, with 2.8 million people (31.4% of the population) in the target age group of 50-74 years. Current CRC screening participation rates in Switzerland are below 50% despite having over 13 screening programs nationwide. The introduction of innovative early detection tests like ColoAlert could significantly improve participation rates, supporting national health goals and addressing a critical gap in prevention efforts [1].

Mainz Biomed’s CEO, Guido Baechler, expressed satisfaction with the regulatory approval, stating, “This supports our broader strategy to expand access to reliable CRC screening solutions for early detection for this devastating disease and ultimately to decrease related mortality rates” [1].

The approval aligns with Mainz Biomed’s decentralized laboratory partnership model, allowing for localized implementation while avoiding the capital intensity of direct market entry. Switzerland represents another proof point in the company's European expansion strategy for ColoAlert®, complementing existing market presence while potentially improving screening compliance rates in a sophisticated healthcare market with established reimbursement pathways [2].

References:
[1] https://www.biospace.com/press-releases/mainz-biomed-receives-swiss-regulatory-approval-to-market-coloalert
[2] https://www.stocktitan.net/news/MYNZ/mainz-biomed-receives-swiss-regulatory-approval-to-market-colo-gzacgw215esa.html