(Nasdaq: MYNZ) Profile

OUR NEW PROFILE IS:   (NASDAQ: MYNZ)

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MAINZ BIOMED (NASDAQ: MYNZ) AIMS TO BECOME A LEADER IN THE MULTI-BILLION-DOLLAR COLORECTAL CANCER DIAGNOSTICS MARKET

CE-IVD cleared flagship product ColoAlert is the first DNA-based screening test for colorectal cancer in Europe

MYNZ is also developing proprietary genetic testing methods for pancreatic cancer in addition to ColoAlert, already on the market in Europe and awaiting approval in the USA.

Check Out the MYNZ Investor Presentation HERE

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Hello Everyone,

Oncology is one of the biggest and fastest growing sectors. According to Fortune Business Insights, the oncology drug market size was valued at $141.33 billion in 2019 and it is expected to reach $394.24 billion in 2027 at an impressive CAGR of 11.6%.

The treatment for cancer is obviously lucrative… but so is its prevention. Scientists and doctors are constantly trying to develop better tools to identify cancer at earlier stages to save lives.  

Since many types of cancer do not present early symptoms, at-home cancer screening kits check for markers that can indicate whether a person has cancer. Tests can detect chemicals that cancer cells produce even before symptoms appear.

This is putting the spotlight on an emerging biotech company that may have a game changing product for Colorectal cancer (CRC) at home testing.

An FDA decision is in the future for this game-changing test that even has the potential to compete with Cologuard wh0 is owned by Exact Sciences Corp, a company that did over $2 Bill in revenue last year with their various testing products.

Pull up MYNZ immediately.

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 currently marketed across Europe and the United Arab Emirates with the intention of beginning its pivotal FDA clinical study in 2022 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.

ColoAlert detects colorectal cancer (CRC) via a simple-to-administer test with a sensitivity and specificity nearly as high as the invasive colonoscopy (Dollinger MM et al., 2018). The test utilizes proprietary methods to analyze cell DNA for specific tumor markers combined with the fecal immunochemical test (FIT). It is designed to detect tumor DNA and CRC cases in their earliest stages. The product is CE-IVDR marked (complying with EU safety, health, and environmental requirements) and is commercially available in a selection of countries in the European Union and the United Arab Emirates. Mainz Biomed currently distributes ColoAlert through a number of clinical affiliates. Once approved in the US, the Company’s commercial strategy is to establish scalable distribution through a collaborative partner program with regional and national laboratory service providers across the country.

FILLING THE IMPORTANT GAP BETWEEN FIT AND COLONOSCOPY. COLOALERT IS THE ONLY CE-IVD DNA BASED TEST AVAILABLE IN EUROPE

Patients receive a simple kit that includes instructions, a stool collector and shipping instructions to return the kit through regular mail to their local lab for testing and results. IT’S THAT EASY.9

Visit www.coloalert.com

9 Currently not approved for use in the USA

10 Comparing ColoAlert sensitivity with FITs (Gies et al. Gastroenterology 154/2018)

11 98% overall satisfaction with ColoAlert in our internal customer survey.

A STRONG PARTNERSHIP FOR SUSTAINABLE GROWTH

DNA extraction for our flagship product ColoAlert is now automated on the Thermo Scientific™ KingFisher™ Apex.

This essential partnership enables laboratories around the world to increase their testing capacity and to optimize their resource allocation.

* Extraction time, does not include sample pre-treatment. For Laboratory Use. © 2022 Thermo Fisher Scientific Inc. All rights reserved. All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified.

PROPRIETARY STATE-OF-THE-ART TECHNOLOGY

*Dollinger MM et al. (2018), ClinLab 64 (10), 1719-1730 and Gies et al. (2018). Gastroenterology 154 (1), 93-104.and Cooper GS et al. (2018). Dig Dis Sci. 63 (6), 1449-1453. * 18 study centres, 566 patients, 10/2018 and Amani et al. (2019). Clin. Lab. 65:1751-1754.

Mainz Biomed Reports Positive Results from Feasibility Study Evaluating its Portfolio of Novel mRNA Biomarkers for Early Detection of Advanced Colorectal Adenomas

  • Mainz Biomed’s proprietary nucleic acid extraction and PCR process proved to be highly effective
  • Two mRNA biomarkers found to be particularly valuable in detecting disease signals in advanced adenoma samples
  • eAArly DETECT clinical trial evaluating these biomarkers with fresh samples reporting results mid-year 2023
  • Results of eAArly DETECT will inform possible inclusion in U.S. Pivotal Clinical Trial (ReconAAsense) assessing Company’s CRC detection test
  • ReconAAsense represents an opportunity to achieve gold standard status for self-administered colorectal cancer (CRC) screening

BERKELEY, Calif. and MAINZ, Germany, March 29, 2023 (GLOBE NEWSWIRE) — Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today results of an independent feasibility study conducted in collaboration with members of the Early Detection Research Network (EDRN) to evaluate the Company’s portfolio of five novel gene expression (mRNA) biomarkers acquired from Université de Sherbrooke in January, 2022.

Data results highlights from this feasibility study include:

  • Mainz’s proprietary nucleic acid extraction process and PCR process is robust and highly reliable – able to consistently obtain DNA and mRNA from patient specimens that were stored for greater than 15 years
  • Two mRNA biomarkers proved powerful in detecting disease signals from these aged specimens
    • Able to detect signals from samples of known colorectal cancer (CRC) patients deemed to have higher levels of CRC-specific transcripts, and from specimens of AA patients where disease is in the early stage and thus CRC-specific transcripts are fewer and harder to detect
    • In univariate analysis, demonstrated statistically significant differences between:
      • CRC specimens and controls p=0.0002 and p=0.001, respectively and more importantly,
      • Advanced adenoma (AA) specimens and controls p=0.0005 and p=0.07 (trend), respectively

“I am extremely pleased with the study’s result as this outcome is exactly what the Mainz team envisioned when acquiring this portfolio of biomarkers, as it is well documented in the medical community that accurate and early detection of CRC and precancerous adenomas plays an integral role in saving lives,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “We now await the mid-year 2023 results of our eAArly DETECT clinical trial evaluating these biomarkers prospectively with fresh, stabilized samples from enrolled patients versus frozen stool samples from up to 15 years ago. We are keen to review the composite of results from both studies to determine which biomarkers are finally selected for integration into our ReconAAsense U.S. pivotal trial for PMA approval. With a way to diagnose both CRC and AA, Mainz has the potential to transform self-administered CRC screening by bringing to market the best-in-class diagnostic test.”

In Sherbrooke’s pioneering work, researchers tested a battery of novel transcriptional biomarkers using samples obtained from patients diagnosed with CRC or as having an advanced adenoma (“AA”), a type of precancerous polyp, and identified a subset of mRNA biomarkers that provided the greatest sensitivity and specificity of detection (Herring et al. 2021). Mainz specifically selected those RNA biomarkers which demonstrated not just the ability to detect a disease signal from samples of patients who were known to have colorectal cancer, but also the unique potential to identify a signal from samples of patients with AA. The power to detect a disease signal in samples from patents with AA can change the entire CRC diagnosis landscape because AA often progresses to CRC, but if treated at the appropriate time AA is curable, CRC can be prevented.

Knowing how fragile mRNA can be, all of Sherbrooke’s research on the mRNA biomarkers was performed using fresh and retrospective stool samples allowing for high quality mRNA extraction, and best-in-class RT-PCR. However, real world CRC testing is often performed with suboptimal patient specimens. Therefore, as part of this feasibility analysis of the “Sherbrooke biomarkers,” the Company utilized banked frozen stool samples provided by the Great Lakes-New England Clinical and Validation Center (GLNE CVC) of the Early Detection Research Network (EDRN). The GLNE includes investigators at several top-tier medical centers including MD Anderson Cancer Center, Dana Farber Cancer Institute, the University of Michigan, NYU Langone Health, the University of Minnesota and others, and is part of the renowned research consortium funded by the Division of Cancer Prevention at the National Cancer Institute (NIH) comprising over 300 academic and industry investigators. The Sherbrooke feasibility protocol involved evaluating 150 samples (50 disease free controls, 51 diagnosed with AA, and 49 from subjects diagnosed with CRC). These banked raw stool specimens were stored for over 15 years at -70°C without any additional stabilization and were exclusively preserved by the surrounding deep freeze temperature. Researchers at the Company first extracted nucleic Acid (DNA and mRNA) and proteins from these samples using their proprietary extraction protocols. Next each extracted mRNA sample was analyzed with the newly acquired RNA biomarkers. The mRNA results were compared with results from fecal immunochemical test (FIT) analysis, hDNA, and mutational status of KRAS and BRAF genes, that together comprise ColoAlert® the Company’s CE-marked, easy-to-use detection test for CRC which is being marketed across Europe and in select international territories. One fascinating outcome from the study was the effectiveness of Mainz’s proprietary extraction technology as it achieved 100% accuracy in detecting nucleic acids from stool samples that have been without stabilization for over 15 years.

The Company now awaits results from the eAArly DETECT clinical trial which commenced enrollment in December of 2022 and remains on track to report results in mid-year 2023. This multi-center feasibility study is enrolling 250 subjects across 25 sites in the U.S. To participate in the study, subjects must be of either average risk for colon cancer or be suspected/known to have an advanced adenoma or CRC. Once eAArly DETECT is completed and the data analyzed, Mainz will compare outcomes from both feasibility studies and select biomarkers for inclusion in the ReconAAsense pivotal trial which will form the data package for review by the U.S. Food and Drug Administration (FDA) to achieve marketing authorization for the Company’s next generation CRC test. ReconAAsense, is a prospective clinical study that will include approximately 15,000 subjects from 150 sites across the United States. It will examine the clinical performance of the Mainz Biomed Colorectal Cancer Screening Test. The study objectives include calculating sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) in average-risk subjects for CRC and AAs. Once enrollment commences, ReconAAsense will continue until at least 73 evaluable subjects are enrolled that are diagnosed with colorectal cancer. To learn more about ReconAAsense please visit clinicaltrials.gov (Identifier: NCT05636085)

Mainz Biomed Announces Partnership with Labor Staber to Expand ColoAlert Commercialization in Germany

Labor Staber to actively market and sell ColoAlert to its physician and patient network.

BERKELEY, Calif. and MAINZ, Germany, March 15, 2023 (GLOBE NEWSWIRE) — Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, 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). For more than 35 years, Labor Staber has been providing physicians and hospitals with medical laboratory services at nine locations across Germany.

“At Mainz, we are on a mission to save lives through the early detection of CRC – the third most common cancer globally – by increasing consumer access to affordable and reliable CRC screening tests like ColoAlert,” said Guido Baechler, Chief Executive Officer of Mainz Biomed. “We continue to build mutually beneficial partnerships with diagnostic labs such as Labor Staber, as we have found putting our PCR testing kits in the hands of highly professional laboratory networks to be a much more effective business model than the traditional methodology of operating testing at a single facility.”

With more than 800 employees, including almost 100 medical specialists, biologists, chemists, and other academics from a wide variety of disciplines, Labor Staber offers a broad range of state-of-the-art medical diagnostics and services from a single source. Under the terms of this agreement, ColoAlert will now be marketed through Labor Staber’s extensive network of physicians and laboratories.

“Our labs combine regional character and collegiality with the organizational competence of a Germany-wide active laboratory group,” said Dr. Thomas Kellerer, Head of Molecular Biology at Labor Staber. “We look forward to working with Mainz as we share the same passion – to improve patients’ lives by using the most advanced analysis methods and equipment, as well as the highest quality standards, in all of our medical diagnostics.”

Mainz Biomed Provides Year-End 2022 Corporate Review

BERKELEY, US and MAINZ, Germany , Jan. 03, 2023 (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 corporate summary for the fiscal year ended December 31, 2022.

Key Commercial, Operational and Product Development Highlights

  • Launched U.S.-based eAArly DETECT study by enrolling the first patient; study focused on the performance of Mainz Biomed’s mRNA biomarkers in identifying Advance Adenomas (AA), a type of pre-cancerous polyp often attributed to colorectal cancer (CRC); on track to report results in 1H 2023.
  • Initiated ReconAAsense, U.S. Pivotal Clinical Study with Company’s CRC screening test; anticipate commencing patient enrollment in mid-2023.
  • Continued executing differentiated business model of partnering with third-party laboratories for test kit processing versus the traditional methodology of operating a single facility.
  • Ramped up international commercial activities for ColoAlert, the Company’s highly efficacious and easy-to-use detection test for CRC, including five new lab partners in Germany and Italy.
  • Enhanced leadership team with appointments to Board of Directors and Company executives to lead commercial and product development groups, with former executives and senior management from Roche, Abbott, Luminex, and Qiagen; expanded Medical Advisory Board of global leaders in molecular diagnostic development.
  • Initiated and commenced patient enrollment in ColoFuture, a European study evaluating the integration of a portfolio of novel gene expression (mRNA) biomarkers into ColoAlert; potential to identify advanced adenomas, a type of pre-cancerous polyp often attributed to CRC; with results expected in 2023.
  • Achieved multiple preclinical milestones supporting the continued development of PancAlert, a potential first-in-class screening test for pancreatic cancer.
  • Acquired a portfolio of novel mRNA biomarkers to upgrade ColoAlert’s technical profile to achieve “gold standard” status for AA and CRC at-home testing.
  • Executed a USD 25.8 million (gross) public follow-on offering.

“The past year has proven to be an extraordinary period of growth as we strengthened every aspect of the Company while expanding our international commercial footprint and executing our product development programs,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “We head into 2023 with a great deal of momentum, and on behalf of the management team and Board of Directors, I wish to extend gratitude to our shareholders for their support as we continue our journey to become a leading provider of cancer-focused early detection and disease prevention molecular diagnostics.”

Commercial Update: Establishing an international market presence for ColoAlert

Throughout 2022, Mainz Biomed executed its differentiated commercial plan of partnering with third-party laboratories for test kit processing versus the traditional methodology of operating a single facility. Under the standard terms of all partnerships, Mainz Biomed is providing ColoAlert to the respective labs, including co-branding with key accounts, whereby each facility purchases Mainz Biomed’s customized polymerase chain reaction (PCR) assay kits on an on-demand basis and provides their respective network of physicians and patients with a comprehensive solution for advanced CRC detection.

Key partnership highlights included establishing high-profile commercial arrangements with leading laboratories such as Labor MVZ Dr. Stein + Kollegen, covering the North Rhine-Westphalia region of Germany, and Dante Labs in Italy and the United Arab Emirates. Labor MVZ Dr. Stein + Kollegen, commonly referred to as “Laboratory Mönchengladbach,” is one of the largest diagnostics laboratories in Germany, servicing over 2,500 physicians, processing over five million samples annually and screening approximately 1,000 patients per week specifically for CRC. Dante Labs is a global leader in genome sequencing with product development and a commercial franchise focused on providing preventive healthcare solutions to consumers and healthcare professionals. Inherent to Dante Lab’s business model is managing state-of-the-art genomic sequencing laboratories in multiple international regions and operating a robust e-commerce platform. With the addition of Laboratory Mönchengladbach and Dante Labs, Mainz Biomed now has five core partnerships, including GANZIMMUN Diagnostics AG, one of Europe’s leading laboratories for preventive and complementary medicine, which processes approximately 5,500 laboratory orders daily. Additional partnership agreements are currently being negotiated with other leading laboratories.

During the year, and specifically in the European region, Mainz Biomed enhanced its commercial strategy to include corporate health programs and direct-to-consumer sales capabilities.

ColoAlert Research and Development Summary: Achieved major clinical development milestones with the goal of upgrading ColoAlert to identify Advanced Adenomas

Over 2022, Mainz Biomed accomplished significant clinical development achievements for ColoAlert based on evaluating acquired mRNA biomarkers to potentially upgrade its technical profile to achieve “gold standard” status for CRC at-home testing. The Company received approval from an independent Institutional Review Board (IRB) and initiated ReconAAsense, a U.S. Pivotal Clinical Study, and commenced enrollment in ColoFuture and eAArly DETECT, an international multi-center clinical study (U.S. and Europe), assessing the potential to integrate mRNA biomarkers into ColoAlert. The mRNA biomarkers being evaluated were acquired from the Université de Sherbrooke in January 2022 and are the result of the institution’s pioneering work in the field, where researchers tested multiple novel transcriptional biomarkers using colorectal cancer and precancerous lesion samples. The results from these studies demonstrated that the mRNA targets chosen by Mainz Biomed provided a market-leading combination of sensitivity and specificity of detection (Herring et al. 2021). The ColoFuture study (extended into the U.S. as eAArly DETECT) is evaluating the effectiveness of these biomarkers to enhance ColoAlert’s technical profile to expand its capability to identify AA while increasing ColoAlert’s rates of diagnostic sensitivity and specificity.

The ColoFuture study is enrolling over 600 patients in the age range of 40-85, and the Company is targeting to report study results in 2023. ColoFuture’s eAArly DETECT study is on track to complete enrollment in Q1 2023, with results reported in the first half of 2023. Based on the study’s outcome, Mainz Biomed will decide on integrating the biomarkers into the ReconAAsense study, which is on track to enroll patients in the summer of 2023, with results reported in 2025.

The ReconAAsense study (ClinicalTrials.gov Identifier: NCT05636085) will form the basis of the data package for review by the U.S. Food and Drug Administration (FDA) to achieve marketing authorization. It is a prospective clinical study that will include approximately 15,000 subjects from 150 sites across the U.S. The study objectives include calculating sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) in average-risk subjects for CRC and AA. If successful, the Company’s mRNA and DNA-based CRC screening test will be positioned as the most robust and accurate at-home diagnostic screening test on the market, as it will not only detect cancerous polyps with a high degree of accuracy but has the potential to prevent CRC through early detection of precancerous adenomas.

PancAlert Research and Development Update: A novel screening test for pancreatic cancer achieved multiple preclinical milestones

During the year, Mainz Biomed announced that PancAlert met multiple preclinical milestones that support the continued development of this potential first-in-class diagnostic for this deadly cancer indication. These predefined milestones included achieving a specificity target, collecting a set of characterized clinical samples, selecting potential biomarker candidates, and developing a prototype biomarker test. The Company plans to continue PancAlert’s research and development to determine if a clinical trial is warranted.

PancAlert’s technical profile may include functioning as a stool-based test, mirroring the Company’s flagship product ColoAlert. Given the growing understanding of the role of the microbiome in pancreatic cancer, Mainz Biomed will evaluate real-time PCR-based multiplex detection of molecular-genetic biomarkers and other testing methods in stool samples and evaluate other collection methodologies, including saliva, urine, and blood.

The PancAlert project commenced in 2020 with a grant from the German Federal Ministry of Education and Research to develop a non-invasive early detection test for pancreatic cancer, a malignant neoplasm of the pancreas with one of the highest mortality rates of all major cancers. Each year, about 466,000 lives are taken globally, and it’s the seventh leading cause of cancer-related death worldwide.1 It has one of the lowest cancer survival rates, with typically late detection and poor outcomes with standard-of-care treatment(s). The 5-year overall survival rate is approximately 11% in the U.S.2 and 9% globally.3 If diagnosis occurs in the early stages of the disease, the survival rate is significantly higher. However, there are currently no routine screening options available.

Corporate Update: Bolstered balance sheet, made key appointments to the management team and enhanced its Board of Directors and Medical Advisory Board

Throughout 2022, Mainz Biomed operated in a position of financial strength, having successfully executed a USD 25.8 million public follow-on offering in January, which consisted of 1,725,000 ordinary shares priced at USD 15.00 per share.

During the year, to keep pace with product development and commercial growth, the Company made it a priority to bolster its leadership team. Key additions to the executive team include:

  • Darin Leigh, Chief Commercial Officer – Mr. Leigh is a former Abbott and Luminex executive with over 30 years of In Vitro Diagnostic (IVD) and life science experience.
  • Amy Levin, Vice President of Regulatory Affairs – Ms. Levin brings to Mainz Biomed over 20 years of regulatory affairs experience. Previously, she worked as Director, Roche Molecular Diagnostics (RMD) International Regulatory Affairs.
  • Jane Edwards, Vice President of Clinical Affairs – Ms. Edwards, has over 20 years of experience developing clinical trial strategies in diagnostics and medical devices. She was previously at L3 Healthcare, a full-service contract research organization, where she led clinical research and operations.
  • Frank Krieg-Schneider, Vice President of Development – Mr. Krieg has over 25 years of experience in the diagnostics and life science industry, including leading various divisions within Qiagen’s diagnostic and life science practice, heading up research and development for Diagnostic Sample Preparation and later serving as Head of Global Strategic Alliances.

Having achieved the transformational corporate growth milestone of going public onto Nasdaq in Q4 2021, Mainz Biomed made it a priority during 2022 to enhance the Company’s Board of Directors and advisory team in order to rely on their vast industry experience for the decisive inflections points in 2023 and beyond. Over the course of the year, Mainz Biomed appointed Dr. Heiner Dreismann as Chairman of the Board, Gregory Tibbitts to its Board of Directors, and added Dr. Michelle Pedrocchi, Dr. Rainer Metzger to its Strategic Advisory Board and Dr. Douglas Rex, Dr. Timothy Wang, and Dr. D. Kim Turgeon to the Medical Advisory Board.

Dr. Dreismann is the former Chief Executive Officer of Roche Molecular Diagnostics and is widely considered a pioneer in PCR, one of the most revolutionary techniques in molecular biology and genetics research. Mr. Tibbitts is an accomplished life science executive and certified public accountant with over 30 years of experience as a senior financial executive and board member of publicly traded and privately held companies.

COMMERCIAL PIPELINE DEVELOPMENT: FUTURE PRODUCTS

IN ADDITION TO THEIR FLAGSHIP COLOALERT PRODUCT, MAINZ BIOMED IS ALSO DEVELOPING:

Developing a novel early detection pancreatic cancer screening test

NEWS

  • GlobeNewswireyesterday

    Mainz Biomed Reports Positive Results from Feasibility Study Evaluating its Portfolio of Novel mRNA Biomarkers for Early Detection of Advanced Colorectal Adenomas

    Mainz Biomed’s proprietary nucleic acid extraction and PCR process proved to be highly effectiveTwo mRNA biomarkers found to be particularly valuable in detecting disease signals in advanced adenoma sampleseAArly DETECT clinical trial evaluating these biomarkers with fresh samples reporting results mid-year 2023Results of eAArly DETECT will inform possible inclusion in U.S. Pivotal Clinical Trial (ReconAAsense) assessing Company’s CRC detection testReconAAsense represents an opportunity to Archie

  • GlobeNewswire4 days ago

    Mainz Biomed Announces Partnership with Labor Staber to Expand ColoAlert Commercialization in Germany

    Labor Staber to actively market and sell ColoAlert to its physician and patient network.BERKELEY, Calif. and MAINZ, Germany, March 15, 2023 (GLOBE NEWSWIRE) — Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, 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 efficac

  • GlobeNewswire11 days ago

    Mainz Biomed Launches Number of Educational Events in Germany to Raise Awareness for CRC Screening and Early Detection

    Sponsor of Gastro Update 2023, 2-day scientific and training events for gastroenterology professionals Patient Education Day in the City of Mainz, Germany, where the Company is headquartered Germany-based molecular diagnostic specialist to support local colorectal cancer communities BERKELEY, Calif. and MAINZ, Germany, March 08, 2023 (GLOBE NEWSWIRE) — Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of

  • GlobeNewswire18 days ago

    Mainz Biomed Recognizes Colorectal Cancer Awareness Month Throughout “Blue” March 2023

    Mainz Biomed to host several events for patients and healthcare professionals in Germany to increase awareness about the importance of early detection of colorectal cancer.BERKELEY, Calif. and MAINZ, Germany, March 01, 2023 (GLOBE NEWSWIRE) — Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, joins advocacy organizations around the world in recognizing Colorectal Cancer Awareness Month in March.

  • GlobeNewswire19 days ago

    Mainz Biomed to Appear on ClearThink IR’s Virtual Live Event on Wednesday, March 1, 2023 at 12 Noon ET

    Virtual Fireside Chat via Paltalk PlatformBERKELEY, Calif. and MAINZ, Germany, Feb. 28, 2023 (GLOBE NEWSWIRE) — Mainz Biomed N.V., a molecular genetics diagnostic company specializing in the early detection of cancer, today announced that its Chief Financial Officer Bill Caragol will appear on ClearThink IR Virtual Live on Wednesday, March 1, 2023 at 12 noon ET. The ClearThink IR Virtual Live, powered by Paltalk, is hosting a different CEO every Wednesday at 12 noon ET for a “fireside chat” fol

  • GlobeNewswire26 days ago

    Mainz Biomed Acquires Entire Intellectual Property Portfolio for its Colorectal Cancer Diagnostic Test Program

    Transaction entails executing option agreements to purchase IP portfolio associated with current ColoAlert product and the novel gene expression (mRNA) biomarkers being evaluated in ColoFuture/eAARLY DETECT Studies BERKELEY, Calif. and MAINZ, Germany, Feb. 21, 2023 (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 the execution of its option from Uni Targeti

  • GlobeNewswirelast month

    Mainz Biomed Expands European Commercial Footprint and Enters Markets in Spain and UK

    Continued roll-out in Europe with onboarding of new lab partnersBERKELEY, Calif. and MAINZ, Germany, Feb. 15, 2023 (GLOBE NEWSWIRE) — Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, 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

  • GlobeNewswire2 months ago

    Mainz Biomed Launches Corporate Health Program in Germany for ColoAlert

    Patient Access Initiative Addresses €1 Billion Annual Market in GermanyBERKELEY, US and MAINZ, Germany, Jan. 18, 2023 (GLOBE NEWSWIRE) — Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, 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 sel

  • GlobeNewswire2 months ago

    Mainz Biomed Provides Year-End 2022 Corporate Review

    BERKELEY, US and MAINZ, Germany , Jan. 03, 2023 (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 corporate summary for the fiscal year ended December 31, 2022. Key Commercial, Operational and Product Development Highlights Launched U.S.-based eAArly DETECT study by enrolling the first patient; study focused on the performance of Mainz Biomed’s mRNA biomar

  • GlobeNewswire3 months ago

    Mainz Biomed Enrolls First Patient in eAArly DETECT Study Evaluating Integration of Novel mRNA Biomarkers into ColoAlert

    Enrollment remains on track to complete in Q1 2023 with results in 1H 2023Potential to identify advanced adenomas, a type of pre-cancerous polyp often attributed to colorectal cancer (CRC) BERKELEY, Calif. and MAINZ, Germany, Dec. 20, 2022 (GLOBE NEWSWIRE) — Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today the first patient has been enrolled in eAArly DETECT, Mainz’s U.S. extend

  • GlobeNewswire3 months ago

    Mainz Biomed Announces IRB Approval and Initiation of US Pivotal FDA Clinical Study

    ReconAAsense study examining the clinical performance of mRNA and DNA test combined with a fecal immunochemical test for early detection of advanced adenoma and colorectal cancer to enroll 15,000 subjects across the United States, results expected in 2025Aims to enhance technical profile of the Mainz Biomed test to identify advanced adenomas (AA), a type of pre-cancerous polyp that can lead to colorectal cancer (CRC)Study will form the basis of the data package for review by the U.S. Food and Dr

  • GlobeNewswire4 months ago

    Mainz Biomed Appoints Amy Levin as Vice President of Regulatory Affairs to Oversee Global Regulatory Strategies

    Former Roche executive Amy Levin, RAC, brings more than 20 years of regulatory affairs experience as an in vitro diagnostics (IVD) industry leaderBERKELEY, Calif. and MAINZ, Germany, Nov. 29, 2022 (GLOBE NEWSWIRE) — Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today the appointment of Amy Levin, RAC, as Vice President of Regulatory Affairs. In this role, Ms. Levin will be in char

  • GlobeNewswire4 months ago

    Mainz Biomed to Participate in Deutsche Eigenkapitalforum and Cantor Fitzgerald’s Medical & Aesthetic Dermatology, Ophthalmology & MedTech Conference

    BERKELEY, Calif. and MAINZ, Germany, Nov. 22, 2022 (GLOBE NEWSWIRE) — Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today that members of its executive team will be participating in two notable conferences in November and December 2022, Deutsches Eigenkapitalforum 2022 and Cantor Fitzgerald’s Medical & Aesthetic Dermatology, Ophthalmology & MedTech Conference. Deutsches Eigenkapit

  • GlobeNewswire4 months ago

    Mainz Biomed Announces U.S. Extension of ColoFuture Study to Evaluate Integration of Novel mRNA Biomarkers into ColoAlert

    eAArly DETECT expected to complete enrollment in Q1 2023 with results in 1H 2023Enhances ColoFuture’s demographic profile and expedites data read-out timelinePotential to identify advanced adenomas, a type of pre-cancerous polyp often attributed to colorectal cancer (CRC) BERKELEY, Calif. and MAINZ, Germany, Nov. 15, 2022 (GLOBE NEWSWIRE) — Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, anno

  • GlobeNewswire5 months ago

MANAGEMENT TEAM

GUIDO BAECHLER

CEO & DIRECTOR

WILLIAM CARAGOL

CFO

KAREN L. RICHARDS

VICE PRESIDENT, REGULATORY

MORITZ EIDENS​ PhD

CSO & DIRECTOR

READ MORE

AMY LEVIN

VP REGULATORY

PHILIPP FREESE ​

COO

DARIN LEIGH

CHIEF COMMERCIAL OFFICER

JANE EDWARDS

VP OF CLINICAL AFFAIRS

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