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 ...

In addition to announcing the results of its Annual General Meeting, Mainz also addresses a recent notification from the Listing Qualifications Department of the Nasdaq Stock Market, LLC ("Nasdaq ") regarding the company's compliance with the minimum bid price requirement. Nasdaq has informed Mainz that it is currently not in compliance with Nasdaq Listing Rule 5550(a)(2), as the closing bid price of the company's ordinary shares was below the minimum of US$1.00 per share for 30 consecutive trading days. Pu ...

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 ...

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 ...