TEST:

ColoAlert

"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...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."

This case report shows the importance of considering CRC as a possible diagnosis in young people. It also demonstrates the usefulness of multitarget stool testing that in this case led to the endoscopic confirmation of the diagnosis followed by an immediate start of potential life-saving treatment.

"Mainz Biomed N.V...today announced significant improvements to its ColoAlert product, currently being commercialized across Europe and in select international markets. These updates aim to enhance customer satisfaction and streamline lab operations."

"Mainz Biomed...announced that it has submitted its application to the U.S. Food and Drug Administration (FDA) requesting Breakthrough Device Designation for its non-invasive Next Generation colorectal cancer (CRC) product including the Company’s novel portfolio of mRNA biomarkers. Subject to the FDA’s review, a Breakthrough Device Designation could significantly accelerate approval."

"Mainz Biomed N.V....will present an analysis from its eAArly DETECT study at Digestive Disease Week (DDW) 2024 in Washington D.C. from May 18th to May 21st. DDW is recognized as a premier forum for the latest advancements in gastroenterology, hepatology, endoscopy, and gastrointestinal surgery....The results show compelling performance of its multimodal screening test combining Fecal Immunochemical Test (FIT), DNA and mRNA biomarkers with a unique artificial intelligence (AI) / machine learning algorithm to differentiate between colorectal cancer (CRC), advanced adenomas (AA), non-advanced adenomas and patient samples with no findings."

"Mainz Biomed...announced today groundbreaking topline results from a pooled clinical study which included new patients and subjects from Mainz Biomed’s ColoFuture (Europe) and eAArly DETECT (U.S.) clinical trials evaluating the potential to integrate its portfolio of proprietary novel gene expression (mRNA) biomarkers into a next generation version of the Company’s colorectal cancer (CRC) screening tool."