COMPANY:

Mainz BioMed

"Mainz Biomed...today announced the signing of a Memorandum of Understanding (“MOU”) with OncoVanguard8, a distributor of oncological innovations. The collaboration aims to introduce ColoAlert®, a DNA-based colorectal cancer (CRC) screening test, to South America, starting with Peru."

''Mainz Biomed N.V...announce the commercial launch of its flagship product, ColoAlert®, in Switzerland...In addition, 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."

"Mainz Biomed N.V...announces today that ColoAlert® has received official registration with the Medicines and Healthcare products Regulatory Agency (MHRA) and is now authorized for marketing in the United Kingdom."

"Mainz Biomed N.V...announces today that ColoAlert®, its non-invasive colorectal cancer (CRC) screening test, has been officially registered and approved for distribution by Swissmedic, the Swiss regulatory and supervisory authority for medicinal products and medical devices."

"Mainz Biomed N.V...today announced a collaboration with CARE diagnostica Laborreagenzien GmbH (“CARE”)"...The cooperation comes into effect immediately and supports Mainz Biomed in further expanding the distribution of ColoAlert® in the German market. It is in line with the growing demand for personalized screening solutions that focus on early intervention."

"Mainz Biomed N.V...announces the commencement of the next phase in its PancAlert project, a research initiative focused on developing a non-invasive blood-based screening test for the early detection of pancreatic cancer. The feasibility phase is intended to confirm the discovery analysis performed in early 2025 in partnership with Liquid Biosciences which demonstrated sensitivity of 95% with specificity of 98% for the detection of pancreatic cancer in blood samples."

"Mainz Biomed N.V...has entered into a technology partnership with UK-based EDX Medical Group plc (AQSE: EDX), which develops innovative digital diagnostic products and services supporting personalized treatments for cancer, cardiovascular and infectious diseases."

"Mainz Biomed N.V...announced today the first patient has been enrolled in eAArly DETECT 2, a feasibility study to evaluate the Company’s next-generation colorectal cancer (CRC) test...The eAArly DETECT 2 study is expected to complete enrollment in the second half of 2025, and the Company targets reporting top-line results by the fourth quarter of 2025. Based on the study’s outcome, Mainz Biomed intends to finalize its protocols for ReconAAsense, the Company’s U.S. pivotal study, which is on track to initiate in 2026."

"Mainz Biomed...announced today it has entered into a License and Option Agreement (the 'Agreement') with Liquid Biosciences ('Liquid') to access a portfolio of novel mRNA biomarkers for the non-invasive detection of pancreatic cancer with a blood test. The parties, under the Agreement, plan to develop this blood-based test for potential future FDA applications. Under the terms of the Agreement, the Company has the rights to develop a test using Liquid’s biomarkers through an exclusive license with the unilateral option to acquire the exclusive global rights to the gene expression biomarkers which have demonstrated a high degree of effectiveness in detecting pancreatic cancer. The financial terms of the Agreement include both a license fee and a royalty on future revenues in the event of the exercise of the option....Liquid used their proprietary EMERGE platform to identify a panel of clinically relevant mRNA biomarkers from a blood-based cohort..."

"Mainz Biomed...announced today the launch of eAArly DETECT 2, a U.S. feasibility study to evaluate the Company’s next generation colorectal cancer (CRC) test, integrating its proprietary mRNA biomarkers, AI developed algorithm and FIT test, over a population of approximately 2,000 patients, all of average risk, to validate the industry leading results of previous feasibility studies, which included average risk and identified risk patients....The eAArly DETECT 2 study is expected to complete enrollment in the second half of 2025 and the Company targets reporting topline results by the fourth quarter of 2025."

"Mainz Biomed N.V...today announced a collaborative agreement with Thermo Fisher Scientific Inc...through its subsidiary Life Technologies Corporation (“Thermo Fisher”)...The collaboration agreement will enable Mainz Biomed and Thermo Fisher to jointly develop and potentially commercialize Mainz Biomed’s Next Generation colorectal cancer screening product."

"Mainz Biomed...announced today increasing demand from existing and prospective laboratory partners for its enhanced ColoAlert product that has been launched in July 2024 and is currently being commercialized across Europe and in select international markets. This advanced version of the Company’s colorectal cancer (CRC) screening test is set to become the standard offering for all existing partners, reflecting its proven benefits in optimizing screening efficiency and improving user experience."