COMPANY:

Mainz BioMed

"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."

"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 is pleased to report the achievement of multiple predefined milestones for the PancAlert project, including achievement of specificity target, collection of a set of characterized clinical samples, selection of potential biomarker candidates, and the development of prototype biomarker tests."

"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)."

"Mainz Biomed N.V...announced today a partnership with Labor MVZ Dr. Stein + Kollegen ('Laboratory Mönchengladbach'). Laboratory Mönchengladbach, one of the largest diagnostics laboratories in the North Rhine-Westphalia region of Germany, will commercialize ColoAlert, Mainz Biomed’s unique, highly efficacious, and easy-to-use detection test for colorectal cancer (CRC)."

"Mainz Biomed...announced today it has commenced ColoFuture, an international clinical study to evaluate 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 which is being commercialized across Europe."

"Mainz Biomed N.V...announced...it has formally contracted with DCN Dx, a leading international developer of point-of-care diagnostics, and provider of comprehensive product development services. An integral part of the engagement will be the role of Emily Friedland, Vice President of Clinical Research at DCN Dx, who will spearhead the preparation and initiation of Mainz’s European centric clinical study to evaluate the potential to integrate a portfolio of recently acquired novel mRNA biomarkers into ColoAlert, the Company’s highly efficacious, and easy-to-use detection test for colorectal cancer."

"Mainz Biomed N.V...announced that it has entered into a Technology Rights Agreement with Socpra Sciences Santé Et Humaines S.E.C. ('TTS') to access a portfolio of novel mRNA biomarkers for potential future integration into ColoAlert, the Company’s highly efficacious, and easy-to-use detection test for colorectal cancer ('CRC')."

"Mainz Biomed N.V...announced today a partnership with leading diagnostics laboratory GANZIMMUN Diagnostics AG (GD), one of Europe’s leading laboratories for preventive and complementary medicine, for the commercialization in Germany of ColoAlert, Mainz’s unique, highly efficacious, and easy-to-use detection test for colorectal cancer."