Mainz Biomed N.V. (NASDAQ:MYNZ) has achieved a significant commercial milestone with the launch of ColoAlert, its flagship DNA-based colorectal cancer screening test, in Switzerland. The molecular genetics diagnostic company announced the commercial availability of the non-invasive test following regulatory approval from Swissmedic, the Swiss therapeutic product regulatory authority.
Strategic Partnership Enables Market Entry
The commercial launch builds on a strategic partnership established earlier this year with labor team w ag, one of Switzerland's leading diagnostic laboratories. This collaboration provides the foundation for ColoAlert's market introduction, ensuring patients and physicians across Switzerland have access to the test through an established and trusted laboratory network.
Mainz Biomed successfully completed a comprehensive technology transfer with labor team, enabling the laboratory to process and analyze ColoAlert samples directly at its state-of-the-art facility in Goldach, Switzerland. This local implementation ensures operational efficiency while guaranteeing Swiss patients benefit from high-quality diagnostics performed within their own healthcare system.
Regulatory Milestones and Market Expansion
ColoAlert has received official registration and marketing approval from Swissmedic, marking an important regulatory step toward expanding patient access to innovative colorectal cancer screening solutions. The test provides a non-invasive approach to colorectal cancer screening by detecting DNA biomarkers in stool samples.
The company has also achieved regulatory success in the United Kingdom, where ColoAlert received official registration with the Medicines and Healthcare products Regulatory Agency (MHRA) and is now authorized for marketing. This approval follows a technology partnership with EDX Medical Group plc, a leading UK laboratory.
Clinical Development Progress
Mainz Biomed continues to advance its clinical development program with the ongoing eAArly DETECT 2 study, a 2,000-patient average risk population study. The company has set a goal of completing enrollment by the end of 2025 and has decided not to pause the study for an interim readout, instead opting to complete enrollment, analysis, and readout on the completed study.
Addressing Significant Medical Need
In the United Kingdom, colorectal cancer represents the fourth most common cancer, with approximately 44,000 new cases diagnosed annually. ColoAlert aims to complement the existing Bowel Cancer Screening Program, which currently invites around 4 million people aged 50 to 74 to complete a FIT test annually, by providing an additional accessible option that could help increase participation in screening programs.
"With the approval, ColoAlert is now cleared for use across the UK," said Guido Baechler, CEO of Mainz Biomed. "This regulatory milestone enables our UK laboratory partner to provide a reliable and user-friendly test to a large population, supporting our shared goal of increasing participation in preventive screening and, ultimately, saving more lives."
Product Portfolio and Technology Platform
ColoAlert is described as an accurate, non-invasive and easy-to-use early-detection diagnostic test for colorectal cancer, currently marketed across Europe and the United Arab Emirates. The company's product candidate portfolio also includes PancAlert, an early-stage pancreatic cancer screening test based on real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in stool samples.
