Latest news with #MainzBiomedN.V
Yahoo
16-05-2025
- Business
- Yahoo
Mainz Biomed Announces Interim Read Out For Its eAArly DETECT 2 Clinical Study
BERKELEY, Calif. and MAINZ, Germany, May 16, 2025 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQ:MYNZ) ('Mainz Biomed' or the 'Company'), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today that it intends to provide an interim read out of its eAArly DETECT 2 feasibility study by the end of summer 2025. The study is evaluating the Company's next-generation colorectal cancer (CRC) screening test that integrates Mainz Biomeds proprietary mRNA biomarkers, an AI-developed algorithm, and a FIT test over a population of approximately 2,000 average-risk patients to validate the industry-leading results of previous feasibility studies and support the transition of CRC screening to CRC prevention. The eAArly DETECT 2 study is expected to complete enrollment in the second half of 2025, and the Company targets reporting top-line results by the fourth quarter of 2025. Based on the study's outcome, Mainz Biomed intends to finalize its protocols for ReconAAsense, the Company's U.S. pivotal study, which is on track to initiate in 2026. This next-generation CRC and APL (Adenomatous Polyps) test will not only detect cancerous polyps with a high degree of accuracy but can potentially prevent the disease through early detection of precancerous adenomas. 'We are excited about the progress the team has been making on eAArly DETECT 2 and look forward to providing partners and shareholders an interim update, targeted for the end of this summer,' commented Guido Baechler, Chief Executive Officer of Mainz Biomed. 'This clinical trial is particularly exciting for the Company, the patient community, and the medical professionals alike. By precisely detecting advanced precancerous lesions and early-stage CRC, we aim to advance our mission of eliminating colorectal cancer and ultimately reducing global cancer mortality rates.' The five novel gene expression (mRNA) biomarkers, which the Company acquired from Sherbrooke University in 2022, have demonstrated a unique ability to identify advanced adenomas – curable precancerous colonic polyps – as well as treatable early-stage CRC. The eAArly DETECT 2 study will further evaluate and confirm the effectiveness of these biomarkers combined with Mainz Biomed's proprietary algorithm to enhance product specifications, extending its capability to include the identification of advanced adenomas while increasing rates of diagnostic sensitivity and specificity for early-stage CRC. Please visit Mainz Biomed's official website for investors at for more information Please follow us to stay up to date:LinkedInX (Previously Twitter)Facebook About Mainz Biomed NVMainz Biomed develops market-ready molecular genetic diagnostic solutions for life-threatening conditions. The Company's flagship product is ColoAlert®, an accurate, non-invasive and easy-to-use, early-detection diagnostic test for colorectal cancer. ColoAlert® is marketed across Europe. The Company is currently running a pivotal FDA clinical study for US regulatory approval. Mainz Biomed's product candidate portfolio also includes PancAlert, an early-stage pancreatic cancer screening test based on real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in stool samples. To learn more, visit or follow us on LinkedIn, Twitter and Facebook. For media inquiries MC Services AGMaximilian Schur / Simone Neeten+49 211 529252 20mainzbiomed@ For investor inquiries, please contact ir@ Forward-Looking Statements Certain statements made in this press release are 'forward-looking statements' within the meaning of the 'safe harbor' provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include information concerning possible or projected future results of our operations, including statements about our clinical trials and studies, business strategies or plans; prospects; future cash flows; financing plans; objectives of management; future cash needs; and any other statements that are not historical facts. Forward-looking statements may be identified by the use of words such as 'anticipate', 'believe', 'expect', 'estimate', 'plan', 'outlook', and 'project' and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements reflect the current analysis of existing information and are subject to various risks and uncertainties. As a result, caution must be exercised in relying on forward-looking statements. Due to known and unknown risks, actual results may differ materially from the Company's expectations or projections. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: (i) the failure to meet projected development and related targets; (ii) changes in applicable laws or regulations; (iii) the effect of the COVID-19 pandemic on the Company and its current or intended markets; and (iv) other risks and uncertainties described herein, as well as those risks and uncertainties discussed from time to time in other reports and other public filings with the Securities and Exchange Commission (the 'SEC') by the Company. Additional information concerning these and other factors that may impact the Company's expectations and projections can be found in its initial filings with the SEC, including its annual report on Form 20-F filed on April 9, 2024. The Company's SEC filings are available publicly on the SEC's website at Any forward-looking statement made by us in this press release is based only on information currently available to Mainz Biomed and speaks only as of the date on which it is made. Mainz Biomed undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, except as required by law.
Associated Press
03-03-2025
- Business
- Associated Press
Colorectal Cancer Awareness Month: Mainz Biomed Advocates for a Shift from Screening to Prevention
BERKELEY, Calif. and MAINZ, Germany, March 03, 2025 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQ:MYNZ) ('Mainz Biomed' or the 'Company'), a molecular genetics diagnostic company specializing in the early detection of cancer, is proud to support Colorectal Cancer Awareness Month in March. Detecting colorectal cancer (CRC) in its early stages significantly improves survival rates, making awareness and proactive screening essential in the fight against this disease. Globally, CRC is the second leading cause of cancer-related deaths, with over 930,000 fatalities annually. In the U.S. it is estimated that over 150,000 people were diagnosed with colorectal cancer, and in Germany, approximately 22,836 individuals succumb to CRC each year, accounting for a substantial portion of cancer-related mortality in the country. Mainz Biomed is committed to combating CRC by advancing diagnostic solutions that focus on early intervention rather than late-stage detection. Through ongoing research, the Company aims to transform the CRC landscape with its next generation product, enabling early detection of pre-cancerous adenomas to improve prevention strategies. Leveraging a combination of mRNA biomarkers, the FIT test, and a proprietary AI algorithm, Mainz Biomed's pooled analysis of the ColoFuture and eAArly DETECT studies demonstrated a groundbreaking advanced adenoma detection sensitivity of 82% and a specificity of 97%. These findings highlight the immense potential for early intervention and reinforce the Company's mission to develop next-generation screening methods that improve patient outcomes and pave the way for more effective prevention strategies in the future. With the current flagship product, ColoAlert®, Mainz Biomed already is enhancing the CRC screening landscape by expanding collaborations with laboratories, including its most recent partnership in Switzerland. By fostering these partnerships, the company is making high-quality, DNA-based screening more widely accessible. Lowering barriers to CRC screening is crucial in empowering both patients and healthcare professionals in early cancer detection. One key initiative is increasing accessibility through at-home testing solutions, now available via one of Mainz Biomed's laboratory partners, European Oncology Lab, through their web-based platform. Colorectal Cancer Awareness Month serves as a crucial reminder that early detection saves lives. Despite being one of the most preventable cancers, CRC remains a leading cause of cancer-related deaths worldwide due to low screening participation. Mainz Biomed is committed to changing this by driving awareness, expanding access to cutting-edge screening solutions, and empowering individuals to take proactive steps in their health. By fostering education, innovation, and accessibility, the Company continues to champion a future where colorectal cancer is detected early—and, ultimately, prevented. About Mainz Biomed NV Mainz Biomed develops market-ready molecular genetic diagnostic solutions for life-threatening conditions. The Company's flagship product is ColoAlert®, an accurate, non-invasive and easy-to-use, early-detection diagnostic test for colorectal cancer. ColoAlert® is marketed across Europe and the United Arab Emirates. The Company is currently running a pivotal FDA clinical study for US regulatory approval. Mainz Biomed's product candidate portfolio also includes PancAlert, an early-stage pancreatic cancer screening test based on real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in stool samples. To learn more, visit or follow us on LinkedIn, Twitter and Facebook. For media inquiries MC Services AG Anne Hennecke / Simone Neeten +49 211 529252 17 For investor inquiries, please contact [email protected] Forward-Looking Statements Certain statements made in this press release are 'forward-looking statements' within the meaning of the 'safe harbor' provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as 'anticipate', 'believe', 'expect', 'estimate', 'plan', 'outlook', and 'project' and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements reflect the current analysis of existing information and are subject to various risks and uncertainties. As a result, caution must be exercised in relying on forward-looking statements. Due to known and unknown risks, actual results may differ materially from the Company's expectations or projections. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: (i) the failure to meet projected development and related targets; (ii) changes in applicable laws or regulations; (iii) the effect of the COVID-19 pandemic on the Company and its current or intended markets; and (iv) other risks and uncertainties described herein, as well as those risks and uncertainties discussed from time to time in other reports and other public filings with the Securities and Exchange Commission (the 'SEC') by the Company. Additional information concerning these and other factors that may impact the Company's expectations and projections can be found in its initial filings with the SEC, including its annual report on Form 20-F filed on April 9, 2024. The Company's SEC filings are available publicly on the SEC's website at Any forward-looking statement made by us in this press release is based only on information currently available to Mainz Biomed and speaks only as of the date on which it is made. Mainz Biomed undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, except as required by law.
Yahoo
20-02-2025
- Business
- Yahoo
Mainz Biomed Expands into Switzerland with labor team w
Partnership to Launch DNA-Based Colorectal Cancer Screening Test BERKELEY, Calif. and MAINZ, Germany, Feb. 20, 2025 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQ:MYNZ) ('Mainz Biomed' or the 'Company'), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today a strategic partnership with labor team w ag ('labor team'), a renowned diagnostic laboratory based in Goldach, Switzerland. This collaboration introduces ColoAlert®, a DNA-based colorectal cancer (CRC) screening test to the Swiss market for the very first time, marking Mainz Biomed's initial footprint in Switzerland. CRC remains one of the most common yet preventable forms of cancer worldwide. In Switzerland, thousands of new cases are diagnosed annually, underscoring the urgent need for early detection and prevention. The introduction of a DNA-based CRC screening test offers a transformative opportunity to increase participation rates and ensure early detection, aligning with national efforts to reduce CRC-related mortality and improve population health outcomes. The new partnership combines Mainz Biomed's expertise in DNA-based diagnostics with labor team w's strong track record in delivering high-quality laboratory services. Together, the companies will provide a state-of-the-art CRC screening test to individuals across Switzerland. 'We are thrilled to partner with labor team to bring this innovative CRC screening solution to the Swiss market,' said Guido Baechler, CEO of Mainz Biomed. 'By integrating our cutting-edge technology into labor team's trusted diagnostic services, we aim to empower individuals with accessible and reliable cancer screening options, ultimately advancing public health.' Alain Cahen, CEO of labor team, adds 'the introduction of ColoAlert® on the Swiss market continues to position labor team as the top innovator of private laboratories, helping more patients access reliable diagnostic tools in key disease areas such as colon cancer screening. This partnership also marks an important milestone for Mainz Biomed, further expanding its presence in the European market with its flagship product ColoAlert®, the first DNA-based CRC screening test in Europe. It aligns with the growing demand for personalized healthcare solutions that prioritize early intervention and prevention. The DNA-based CRC screening test will be available through labor team w´s extensive network of healthcare providers starting in the spring 2025. Please visit Mainz Biomed's official website for investors at for more information Please follow us to stay up to date:LinkedInX (Previously Twitter)Facebook About Mainz Biomed NVMainz Biomed develops market-ready molecular genetic diagnostic solutions for life-threatening conditions. The Company's flagship product is ColoAlert®, an accurate, non-invasive and easy-to-use, early-detection diagnostic test for colorectal cancer. ColoAlert® is marketed across Europe and the United Arab Emirates. The Company is currently running a pivotal FDA clinical study for US regulatory approval. Mainz Biomed's product candidate portfolio also includes PancAlert, an early-stage pancreatic cancer screening test based on real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in stool samples. To learn more, visit or follow us on LinkedIn, Twitter and Facebook. About labor team labor team w ag, based in Goldach in the canton of St Gallen, is one of Switzerland's leading private medical laboratories. Established in 2001 and run by medical professionals, it is now the fourth largest laboratory in Switzerland, with over 300 employees. labor team is one of the few laboratories that serves the whole of Switzerland. It provides professional services for disease prevention, diagnosis, monitoring and treatment of illnesses. The company covers every aspect of laboratory medicine and pathology. It performs medical tests and analyses in a state-of-the-art central laboratory, resulting in top quality services, a high level of flexibility and fast turnarounds. For more information, visit: For media inquiriesMC Services AGAnne Hennecke/Simone Neeten+49 211 529252 22mainzbiomed@ For investor inquiries, please contact ir@ Forward-Looking StatementsCertain statements made in this press release are 'forward-looking statements' within the meaning of the 'safe harbor' provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as 'anticipate', 'believe', 'expect', 'estimate', 'plan', 'outlook', and 'project' and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements reflect the current analysis of existing information and are subject to various risks and uncertainties. As a result, caution must be exercised in relying on forward-looking statements. Due to known and unknown risks, actual results may differ materially from the Company's expectations or projections. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: (i) the failure to meet projected development and related targets; (ii) changes in applicable laws or regulations; (iii) the effect of the COVID-19 pandemic on the Company and its current or intended markets; and (iv) other risks and uncertainties described herein, as well as those risks and uncertainties discussed from time to time in other reports and other public filings with the Securities and Exchange Commission (the 'SEC') by the Company. Additional information concerning these and other factors that may impact the Company's expectations and projections can be found in its initial filings with the SEC, including its annual report on Form 20-F filed on April 9, 2024. The Company's SEC filings are available publicly on the SEC's website at Any forward-looking statement made by us in this press release is based only on information currently available to Mainz Biomed and speaks only as of the date on which it is made. Mainz Biomed undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, except as required by law.
