Core Insights - Mainz Biomed N.V. has announced significant improvements to its ColoAlert product aimed at enhancing customer satisfaction and streamlining laboratory operations [9][10] - The updated ColoAlert product features a novel DNA stabilizing buffer that accommodates varying sample volumes, reducing the need for retesting and expediting result delivery to patients [3][10] - Colorectal cancer (CRC) represents a substantial market opportunity, with over 1.9 million new cases reported globally in 2020 and a $4.0 billion+ market opportunity in the US due to screening gaps [11][12] Company Developments - The ColoAlert product is now accessible to existing laboratory partners and available for prospective collaborators, indicating a focus on expanding market reach [4] - Enhancements to the ColoAlert kit include improved usability features such as a new collection device and tube holder, aimed at providing a more straightforward user experience [10] - Mainz Biomed is planning to conduct a pivotal FDA clinical study for US regulatory approval of ColoAlert, indicating a strategic move to enter the US market [12] Industry Context - CRC is the third most common cancer worldwide, with significant screening recommendations from health authorities, highlighting the importance of early detection tests like ColoAlert [11] - The US Preventive Services Task Force recommends stool DNA tests every three years starting at age 45, emphasizing the need for effective screening solutions [11] - Approximately one-third of US residents aged 50-75 have never been screened for colon cancer, representing a critical gap in healthcare that Mainz Biomed aims to address [11]

On the basis of its positive clinical studies Mainz Biomed has now defined the final configuration including its novel mRNA biomarkers of the Next Generation Test to be used in pivotal registration study ReconAAsense A recent clinical analysis of this new configuration demonstrates sensitivity for colorectal cancer of 97% and 88% for advanced adenomas, with specificity of 93% BERKELEY, Calif. and MAINZ, Germany, July 09, 2024 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQ: MYNZ), a molecular genetics diagnos ...

BERKELEY, Calif. and MAINZ, Germany, July 02, 2024 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQ: MYNZ), a molecular genetics diagnostic company specializing in the early detection of cancer, today reviewed its major accomplishments of the first six months ending June 30, 2024, and provided a corporate update. The Company expects to release its half year financial results in September 2024. Key Highlights During First Half 2024 "I'm extremely pleased with the progress achieved during the first half of 2024 ...

BERKELEY, Calif. and MAINZ, Germany, July 02, 2024 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQ: MYNZ), a molecular genetics diagnostic company specializing in the early detection of cancer, today reviewed its major accomplishments of the first six months ending June 30, 2024, and provided a corporate update. The Company expects to release its half year financial results in September 2024. Key Highlights During First Half 2024 Mainz Biomed presented industry leading results of its pooled study at ASCO 2024 ...

New study data confirmed previous ColoFuture and eAArly DETECT study performance with sensitivity for CRC of 92% and 82% for advanced adenomas, including 95.8% detection of high-grade dysplasia Results from pooled study represents the third consecutive confirmation of the consistently good performance of Mainz Biomed's mRNA biomarkers to detect CRC and precancerous lesions BERKELEY, Calif. and MAINZ, Germany, June 03, 2024 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQ: MYNZ), a molecular genetics diagnostic ...

New study data confirmed previous ColoFuture and eAArly DETECT study performance with sensitivity for CRC of 92% and 82% for advanced adenomas, including 95.8% detection of high-grade dysplasia Results from pooled study represents the third consecutive confirmation of the consistently good performance of Mainz Biomed's mRNA biomarkers to detect CRC and precancerous lesions BERKELEY, Calif. and MAINZ, Germany, June 03, 2024 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQ: MYNZ), a molecular genetics diagnostic ...

Core Insights - Mainz Biomed N.V. held its Annual General Meeting on May 31, 2024, in Amsterdam, with 2,431,947 ordinary shares represented, constituting approximately 10.9% of outstanding shares [1] - All proposals presented at the meeting received requisite shareholder approval, including the adoption of statutory annual accounts and the reappointment of directors [1] Proposal Outcomes - Adoption of statutory annual accounts for the financial year ended December 31, 2023: 2,400,449 votes for, 22,528 against, 8,970 abstained [1] - Discharge from liability of directors for management during the financial year ended December 31, 2023: 2,187,602 votes for, 198,949 against, 45,396 abstained [1] - Amendment of articles of association: 2,344,801 votes for, 32,166 against, 54,980 abstained [1] - Extension of board's authorization to acquire ordinary shares: 2,229,837 votes for, 169,972 against, 32,138 abstained [1] - Reappointment of executive and non-executive directors received strong support, with votes for ranging from 2,368,376 to 2,378,154 [1] Nasdaq Compliance Update - Mainz Biomed is currently not in compliance with Nasdaq's minimum bid price requirement, as its ordinary shares have been below $1.00 for 30 consecutive trading days [2] - The company has been granted a 180-day compliance period to regain compliance, with a deadline of November 25, 2024 [2] - If compliance is not regained, the company may appeal Nasdaq's determination and request a hearing [2] Company Overview - Mainz Biomed specializes in molecular genetic diagnostic solutions for early cancer detection, with its flagship product, ColoAlert®, marketed across Europe [3] - The company plans to conduct a pivotal FDA clinical study for US regulatory approval and has a product candidate portfolio that includes PancAlert for pancreatic cancer screening [3]

Core Insights - Mainz Biomed N.V. announced significant findings from the ColoFuture and eAArly DETECT studies, demonstrating a sensitivity of 92.3% for colorectal cancer and 82.3% for advanced precancerous lesions [1][2] Company Overview - Mainz Biomed specializes in molecular genetics diagnostics, focusing on early cancer detection, with its flagship product being ColoAlert®, a non-invasive test for colorectal cancer [6] - The company is preparing for a pivotal FDA clinical study to gain regulatory approval for its products in the U.S. market [6] Study Details - The combined analysis from the ColoFuture and eAArly DETECT studies involved 690 subjects across 30 clinical sites, making it the largest dataset to date for this type of research [2] - The studies utilized a novel stool-based approach that integrates mRNA biomarkers and the Fecal Immunochemical Test (FIT) with an AI-generated algorithm to enhance diagnostic performance [2][4] Presentation Information - The findings will be presented at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting, highlighting the test's significant improvement over existing non-invasive methods for detecting advanced precancerous lesions [3] Market Context - Colorectal cancer is the third most common cancer globally, with over 1.9 million new cases reported in 2020, indicating a substantial market opportunity for effective screening solutions [5] - In the U.S., approximately 16.6 million colonoscopies are performed annually, yet about one-third of residents aged 50-75 have never been screened, representing a market opportunity exceeding $4.0 billion [5]

Key Findings: 92.3% Sensitivity for Colorectal Cancer, 82.3% for Advanced Precancerous Lesions Poster presentation showing new data on 690 subjects including previously unexamined and unreported samples from the pooled ColoFuture and eAArly DETECT studies utilizing the mRNA biomarkers, FIT test, and a proprietary AI Algorithm BERKELEY, Calif. and MAINZ, Germany, May 28, 2024 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQ: MYNZ), a molecular genetics diagnostic company specializing in the early detection of c ...

Mainz Biomed Presented Industry Leading Results: 97% Sensitivity for Colorectal Cancer, 82% for Advanced Precancerous Lesions The eAArly DETECT results demonstrated that within the advanced precancerous lesion patients, 100% of those patients with high grade dysplasia were detected The Company's mission is to transform current colorectal cancer screening practices, and ultimately to reduce cancer mortality rates worldwide by shifting from cancer detection to cancer prevention BERKELEY, Calif. and MAINZ, Ger ...