Mainz Biomed's ColoAlert approved for distribution in Switzerland.

Mainz Biomed's non-invasive colorectal cancer (CRC) screening test, ColoAlert, has been officially registered and approved for distribution by Swissmedic, the Swiss regulatory and supervisory authority for medicinal products and medical devices. The test is aimed at individuals aged 50-74, a demographic with an estimated 2.8 million people in Switzerland, making up 31.4% of the population. Despite existing screening programs, participation rates are below 50%.

Mainz Biomed (NASDAQ:MYNZ) has achieved a significant regulatory milestone with Swissmedic approval for ColoAlert®, its non-invasive colorectal cancer (CRC) screening test in Switzerland. This approval strategically positions the company within a market where 2.8 million individuals (31.4% of Switzerland's population) fall within the recommended 50-74 age screening demographic [1].

The Swiss market represents a significant opportunity, with current colorectal cancer screening participation rates below 50% despite having over 13 screening programs nationwide [1]. ColoAlert®, designed to detect CRC tumor DNA and other biomarkers in stool samples, aims to improve these participation rates.

Mainz Biomed secures Swiss approval for ColoAlert, unlocking access to 2.8M potential screening candidates with established lab partner. The approval follows the company's partnership with labor team w ag, a local Swiss laboratory [1]. The timing is particularly advantageous as current Swiss colorectal cancer screening participation rates sit below 50% despite established programs nationwide. This presents a clear market opportunity for Mainz Biomed's ColoAlert® test, which offers an alternative to traditional screening methods like the biennial Fecal Immunochemical Test or once-per-decade colonoscopies [1].

What makes this approval particularly valuable is that Mainz already has its commercialization infrastructure in place through a previously announced partnership with local laboratory partner labor team w ag. With no remaining regulatory hurdles, the company can immediately proceed with market launch, accelerating the revenue timeline [1].

This 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 [1].

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