TEST:

ColoAlert

"Mainz Biomed N.V...is proud to announce its upcoming participation at the 39th UDH Congress 2024, taking place on March 16th & 17th in Fellbach, Germany. One of the main focus topics for this year’s event, organized by the German Complementary Medicine Association (Union Deutscher Heilpraktiker, Landesverband Baden-Württemberg), is the gut and its significance in the manifestation of diseases....By presenting ColoAlert at the UDH Congress, Mainz Biomed highlights the role of cutting-edge molecular diagnostics in enhancing comprehensive health strategies, demonstrating the synergy between technological innovation and patient-centric care."

"Mainz Biomed N.V...announced today a partnership with Trusted Health Advisors (THA), a market leader in supporting the U.S. launches and management of commercial programs for diagnostic products...In the U.S., Mainz Biomed is in final regulatory planning stages of ReconAAsense clinical trial to seek Premarket Approval (PMA) for its next generation diagnostic test...'As we make the final preparations to commence patient enrollment in the ReconAAsense trial and given the potentially transformative role the test will have on the market if approved, we are excited by the opportunity to be in a position to advance our U.S. go-to-market strategy for our innovative approach in CRC screening.'....'Through our partnership with THA, we plan to expedite and enhance the deployment of our differentiated commercial strategy to enable an efficient and impactful transition to the marketplace for the product which if approved, we anticipate will occur in 2026.'"

"Mainz Biomed...s pleased to announce a distribution partnership with Praxisdienst...This collaboration, which commenced in February 2024, marks an important step in Mainz Biomed’s mission to enhance healthcare delivery across Germany, focusing on the accessibility of their flagship product, ColoAlert®."

"Mainz Biomed N.V...announced today a strategic partnership with TomaLab to launch the Company’s flagship product, ColoAlert in Italy. TomaLab is one of Italy’s premier biotechnology laboratories and is based in Milan. The partnership signifies a major step forward in enhancing colorectal cancer screening and diagnostics within the Italian healthcare system as it enables the implementation of ColoAlert into Italy's robust healthcare framework, providing patients with access to a cutting-edge diagnostic solution that combines convenience with clinical excellence."

"Mainz Biomed...announces the opening of the ‘European Oncology Lab’ (EOL). The physician-led facility represents an expansion of the Company’s collaboration with Laboratory Dr. Buhlmann with a shared location in Saarland, Germany...Via the EOL, medical professionals or patients can now order ColoAlert® directly with Mainz Biomed as a laboratory medical service, meeting a crucial requirement to invoice private health insurance companies."

"Mainz Biomed N.V. announced a year end summary of its corporate and product development progress...Announced groundbreaking results from ColoFuture (Europe) and eAArly DETECT (U.S.) clinical studies evaluating the potential to integrate portfolio of novel gene expression (mRNA) biomarkers into a next generation version of ColoAlert."

"Mainz Biomed N.V...announced today its active participation alongside Polish partner TestDNA at two significant gastroenterology conferences in Poland, strengthening their commitment to advancing colorectal cancer (CRC) detection and gastroenterological innovation....The first attended conference, the 17th Conference: Advances in Gastroenterology, ran from December 8th to 9th, 2023, in Poznań....Following this, Mainz Biomed will be taking part in the 10th Gdańsk Gastroenterology Symposium which runs from January 12th to 13th, 2024."

"Mainz Biomed N.V...announced today groundbreaking topline results from its eAArly DETECT U.S. clinical study, a multi-center feasibility study assessing the potential to integrate a portfolio of novel gene expression (mRNA) biomarkers into a next generation version of ColoAlert®, the Company’s highly efficacious and easy-to-use screening test for colorectal cancer (CRC) being commercialized across Europe and in select international territories. The eAArly DETECT topline results reported a sensitivity for colorectal cancer of 97% with a specificity of 97% and a sensitivity for advanced adenoma of 82%. They confirm the positive results from ColoFuture, its European counterpart which reported data in October 2023."

"Mainz Biomed NV...announced a strategic partnership with Liquid Biosciences, a bio-analytics company leveraging its proprietary AI analysis technology platform (EMERGE) to serve the biopharma and diagnostics industries along with academic institutions."

"Mainz Biomed N.V...announced that VP Commercial Operations, Tarrin Khairi-Taraki, will attend MEDICA by invitation of the Rhineland-Pfalz government."

P=NA | N=NA | "Mainz Biomed N.V...a molecular genetics diagnostic company specializing in the early detection of cancer is presenting its groundbreaking results of its ColoFuture Study....The presented results of the groundbreaking study included a sensitivity for CRC of 94% with a specificity of 97% and a sensitivity for advanced adenoma (AA) of 80%."

"Mainz Biomed NV...announced today its participation in the upcoming UEG Week. This prominent event, organized by the United European Gastroenterology and scheduled to take place in Copenhagen, Denmark, from October 14th to 17th, serves as a premier platform for discussing the latest advancements and breakthroughs in the field of gastroenterology."

"Mainz Biomed NV...announces the live launch of Mainz Biomed’s flagship product, ColoAlert^® — a highly effective and user-friendly at-home detection test for colorectal cancer (CRC) - with strategic partner Bioclinica, a national leader in the Romanian healthcare sector. This partnership signifies a pivotal step towards enhancing healthcare outcomes in the country through advanced diagnostics....The collaboration with Bioclinica adds significant value to Mainz Biomed's mission."

"Mainz Biomed N.V...announced today that it will present the positive detailed results from its ColoFuture study at the 4th International Conference on Gastroenterology which occurs on October 16th - 18th in Paris, France. The ColoFuture study was a multi-center international clinical trial assessing the potential to integrate a portfolio of novel gene expression (mRNA) biomarkers into ColoAlert®, the Company’s highly efficacious, and easy-to-use screening test for colorectal cancer (CRC) being commercialized across Europe and in select international territories."

"Mainz Biomed N.V...announced positive topline results from its ColoFuture study. The ColoFuture study is a multi-center international clinical trial assessing the potential to integrate a portfolio of novel gene expression (mRNA) biomarkers into ColoAlert, the Company’s highly efficacious, and easy-to-use screening test for colorectal cancer (CRC) which is being commercialized across Europe and in select international territories. The results of this groundbreaking study included sensitivity for colorectal cancer of 94% with a specificity of 97% and a sensitivity for advanced adenoma of 81%."

"Mainz Biomed N.V...announced today a strategic partnership with Ärztliches Labor Dr. Buhlmann, a move aimed at further strengthening its position in the German market...The collaboration grants Mainz Biomed greater access to, and the potential for further expansion into Germany’s private health insurance segment where ColoAlert, its highly efficacious, and easy-to-use detection test for colorectal cancer (CRC), already receives reimbursement."

"Mainz Biomed NV...announces the commercial launch of ColoAlert® in Poland, made possible through a strategic collaboration with testDNA Sp. z o. o. Sp. K...The partnership marks another significant step forward in providing new and innovative testing options to underserved populations in the battle against colorectal cancer ('CRC')."

"Mainz Biomed NV...announced today that London-based Marylebone Laboratory (Marylebone Lab Ltd) has introduced ColoAlert, Mainz Biomed’s flagship product—a highly effective and user-friendly at-home detection test for colorectal cancer (CRC) – to its extensive UK and international customer base. Further strengthening Mainz Biomed’s global network of esteemed laboratory partners, the collaboration marks another significant milestone in the Company’s mission to combat colorectal cancer (CRC) and save lives through advanced diagnostics."

"Mainz Biomed NV...announces today its commercial partnership for ColoAlert with Fugene Genetics, a renowned genetic testing service provider based in Israel."

ColoAlert is the only stool DNA test currently sold in Europe and is available at a lower price than Cologuard, but reliable evidence is lacking. A screening study including the current product version of ColoAlert and suitable comparators would, therefore, help evaluate the effectiveness of this screening option in a European context.

"Mainz Biomed NV...announce its participation in the highly anticipated ESMO World Congress on Gastrointestinal Cancer 2023. The event, organized by the European Society for Medical Oncology and held in Barcelona, Spain from June 28th to July 1st, serves as a platform for sharing cutting-edge research and innovations that are revolutionizing the field of gastrointestinal oncology...the companies will showcase ColoAlert, the innovative at-home screening test for CRC by Mainz Biomed."

"Mainz Biomed NV...announce the addition of Bioclinica to its esteemed network of laboratory partners. Bioclinica will play a crucial role in supporting the commercialization efforts of ColoAlert, Mainz Biomed’s flagship product—a highly effective and user-friendly at-home detection test for colorectal cancer (CRC). This strategic collaboration marks another milestone in Mainz Biomed’s mission to revolutionize the diagnosis and prevention of life-threatening diseases, particularly CRC, which continues to be the second most lethal cancer in Europe."

"Mainz Biomed NV...announced today the establishment of a commercial partnership for ColoAlert with TESTDNA Sp. z o.o. Sp. k. Katowice, Poland, a leading independent laboratory in Poland."

"Mainz Biomed NV...announced today initial results from its colorectal cancer (CRC) screening campaign through its BGM ('betriebliches Gesundheits management') partnership with Zoller -Kipper GmbH, part of the Zoller group with more than 2,500 employees. In April 2023, Zoller -Kipper selected ColoAlert, Mainz Biomed’s highly efficacious and easy-to-use screening test for CRC, for its corporate health program."

"Mainz Biomed NV...announced today that it has added Eurofins GeLaMed to its network of lab partners offering PCR test kit processing of ColoAlert, its flagship product that is a highly efficacious and easy to use at-home screening test for colorectal cancer (CRC)."

"Mainz Biomed NV...announced that it has added the Instituto de Microecologia in Madrid to its growing network of lab partners across Europe and in select international markets. ColoAlert®, Mainz Biomed’s flagship product, is a highly efficacious and easy-to-use, at-home detection test for colorectal cancer (CRC)."

"Mainz Biomed NV...announced today that three German-based companies, have selected ColoAlert, the Company’s highly efficacious and easy-to-use screening test for colorectal cancer (CRC) into their respective corporate health programs."

"Mainz Biomed NV...announced today a partnership with Dr Staber & Kollegen GmbH (Labor Staber) as part of its growing network of laboratories offering ColoAlert, its flagship product that is a highly efficacious and easy-to-use at-home screening test for colorectal cancer (CRC)."

"Mainz Biomed N.V...announced today the execution of its option from Uni Targeting Research AS to acquire all of the previously licensed scientific intellectual property ('IP') for its flagship product ColoAlert, a highly efficacious, and easy-to-use detection test for colorectal cancer (“CRC”) being commercialized across Europe."

"Mainz Biomed NV...announced today the establishment of commercial partnerships for ColoAlert with Marylebone Laboratory (Marylebone Lab LTD) and Instituto de Microecologia, two leading independent laboratories covering England and Spain."

"Mainz Biomed NV...announced today the launch of a corporate health program in Germany for ColoAlert, its highly efficacious and easy-to-use screening test for colorectal cancer (CRC) being commercialized across Europe and in select international territories."

"Mainz Biomed NV...announced today the first patient has been enrolled in eAArly DETECT, Mainz’s U.S. extension of ColoFuture, its European feasibility study evaluating the integration of a portfolio of novel gene expression (mRNA) biomarkers into ColoAlert.Currently, Mainz is commercializing ColoAlert, its highly efficacious, and easy-to-use detection test for colorectal cancer (CRC) across Europe and in select international territories....Mainz expects to complete enrollment for the eAArly DETECT in Q1 2023 and targets reporting topline results in 1H 2023. Based on the study’s outcome, the Company will determine which of the biomarkers are eligible for inclusion in the Company’s U.S. pivotal trial (ReconAAsense), which is on schedule to begin enrolling patients in 2023 with results expected in 2025."

"Mainz Biomed said Tuesday that it has received approval from an independent institutional review board for the trial protocol of its ReconAAsense study. The study, which will recruit 15,000 individuals across the US, is to evaluate the clinical performance of the firm's colorectal cancer early detection test in order to support a submission for review by the US Food and Drug Administration...Mainz's ColoAlert assay combines analysis of DNA, mRNA, and fecal immunohistochemistry to identify cancer in asymptomatic individuals from a stool sample. The company currently markets the test across Europe and the United Arab Emirates."

"Mainz Biomed NV...announced today the initiation of eAArly DETECT, its U.S. extension of ColoFuture, the Company’s European feasibility study evaluating the integration of a portfolio of novel gene expression (mRNA) biomarkers into ColoAlert, Mainz’s highly efficacious, and easy-to-use detection test for colorectal cancer (CRC) being commercialized across Europe and in select international territories."

Corporate Presentation: US launch in 2026

"Mainz Biomed N.V...and Dante Genomics...announced today the formal commencement of ColoAlert’s consumer commercial program in Italy and the United Arab Emirates (UAE). ColoAlert is Mainz’s flagship product, a highly efficacious and easy to use, at-home detection test for colorectal cancer (CRC) currently being commercialized across Europe and select international markets. With the ColoAlert test CE-IVD certified and patient collection kit CE marked to the latest IVDR requirements, ColoAlert will now be marketed through Dante’s extensive database and sold via Dante’s, region-specific, ecommerce websites."

"Mainz Biomed N.V...announced today it has enrolled the first patient in ColoFuture, an international clinical study assessing the potential to integrate a portfolio of novel gene expression (mRNA) biomarkers into ColoAlert, the Company’s highly efficacious, and easy-to-use detection test for colorectal cancer (CRC) which is being commercialized across Europe...The ColoFuture study is evaluating the effectiveness of these biomarkers to enhance ColoAlert’s technical profile to extend its capability to include the identification of advanced adenomas (AA), a type of pre-cancerous polyp often attributed to CRC, while increasing ColoAlert’s rates of diagnostic sensitivity and specificity."

"Mainz Biomed N.V...announced today that it has successfully completed the conformity assessment of its internal processes to In Vitro Diagnostic Devices Regulation (IVDR) compliance which becomes mandatory from May 26, 2022. Additionally, the ColoAlert patient kit is now CE marked to the IVDR requirements, a significant milestone and achievement for the company...Meeting conformity assessment requirements to IVDR compliance for ColoAlert, Mainz Biomed’s highly efficacious, and easy-to-use detection test for colorectal cancer (CRC), involves meeting new standards for the CE mark of its stool collection tool."

"Mainz Biomed N.V...announced today a partnership for the commercialization of ColoAlert in Italy and the United Arab Emirates (UAE). ColoAlert is Mainz’s flagship product, a highly efficacious and easy to use at-home detection test for colorectal cancer (CRC)."

"Mainz Biomed N.V....announced today that it has received supportive feedback from the U.S. Food & Drug Administration (FDA) on the Company’s pre-submission package profiling the potential pivotal clinical trial design for ColoAlert, its highly efficacious, and easy-to-use detection test for colorectal cancer (CRC). As Mainz prepares to launch ColoAlert’s pivotal clinical trial, the Company is also pleased to announce the formal commencement of its reimbursement process for ColoAlert by scheduling an initial meeting with The Centers for Medicare and Medicaid Services (CMS) in April 2022....The results of the study will ultimately impact the configuration of ColoAlert prior to commencing the U.S. pivotal study which is on track to begin in late 2022."

"Mainz Biomed N.V....today partnerships with Sentinel Diagnostics and Alcedis GmbH to support ColoFuture, its clinical study evaluating the potential to integrate a portfolio of novel mRNA biomarkers into ColoAlert, the Company’s highly efficacious, and easy-to-use detection test for colorectal cancer (CRC)....In addition to the Sentinel appointment, Mainz is pleased to partner with Alcedis GmbH, a full-service state-of-the-art contract research organization (CRO) providing clinical trial management for biotechnology and medical device companies across the globe. Under the terms of the engagement, Alcedis will provide Mainz with the full range of services and responsibilities associated with executing ColoFuture, including patient recruitment, overseeing study protocol compliance, and the documentation and reporting of patient results....The Company expects to complete enrollment during the second half of 2022 and is targeting reporting study results in early 2023...."

"Mainz Biomed N.V...announced today that its pre-submission filed with the U.S. Food & Drug Administration (FDA) for ColoAlert has been accepted for review. By accepting the pre-submission for review, the FDA will provide feedback to the Company on its proposed pivotal U.S. clinical trial design for ColoAlert, its highly efficacious, and easy-to-use detection test for colorectal cancer (CRC)."