Articles from Mainz BioMed NV

BERKELEY, Calif. and MAINZ, Germany, Jan. 27, 2025 (GLOBE NEWSWIRE) -- Mainz Biomed NV (NASDAQMYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today that on January 23, 2025, the Company received formal notice from The Nasdaq Stock Market LLC (“Nasdaq”) confirming that it has regained compliance with the minimum stockholders’ equity requirement for continued listing on the Nasdaq Capital Market set forth in Listing Rule 5550(b)(1). Mainz Biomed had previously received confirmation that it had regained compliance with the minimum bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2). Mainz Biomed is now in full compliance with all Nasdaq continued listing requirements and will continue to be listed and traded on The Nasdaq Capital Market.

eAArly DETECT 2 feasibility study designed to validate earlier results on advanced adenomas over a large population of average risk patients

Quest to Support Mainz Biomed’s ReconAAsense FDA Study and Has Option to Commercialize Test Kit Assuming FDA Approval

BERKELEY, Calif. and MAINZ, Germany, Dec. 16, 2024 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQMYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, today announced the closing of its previously announced follow-on offering of 1,367,521 units, with each unit consisting of one ordinary share (or prefunded warrant in lieu thereof) one Class A warrant to purchase one ordinary share, and one Class B warrant to purchase one ordinary share for gross proceeds of approximately $8.0 million. Each unit was sold at an effective offering price of $5.85 per unit, priced at-the-market under Nasdaq rules. Each Class A warrant is immediately exercisable at an exercise price of $5.85 per share and will expire five years from the date of issuance. Each Class B warrant is immediately exercisable at an exercise price of $5.85 per share and will expire on the earlier of 30 days following receipt of results from the Company’s eAArly Detect 2 study, and one year from the date of issuance.

BERKELEY, Calif. and MAINZ, Germany, Dec. 12, 2024 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQMYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, today announced the pricing of a follow-on offering of 1,367,521 units, with each unit consisting of one ordinary share (or prefunded warrant in lieu thereof) one Series A warrant to purchase one ordinary share, and one series B warrant to purchase one ordinary share for gross proceeds of approximately $8.0 million. Each unit is being sold at an effective offering price of $5.85 per unit, priced at-the-market under Nasdaq rules. Each Series A warrant will be immediately exercisable at an exercise price of $5.85 per share and will expire five years from the date of issuance. Each Series B warrant will be immediately exercisable at an exercise price of $5.85 per share and will expire on the earlier of 30 days following receipt of results from the Company’s eAArly Detect 2 study, and one year from the date of issuance.

BERKELEY, Calif. and MAINZ, Germany, Nov. 29, 2024 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQMYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, today announced a 1-for-40 reverse stock split of its issued and outstanding shares. The reverse stock split was authorized by the Board of Directors of the Company pursuant to shareholder approval granted at its Extraordinary Shareholders Meeting on November 20, 2024.

BERKELEY, Calif. and MAINZ, Germany, Nov. 12, 2024 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQMYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, today announced a collaborative agreement with Thermo Fisher Scientific Inc. NYSE: TMONYSETMO)

Revenue increases 4% year over year while loss from operations decreases by 32%

GANZIMMUN Diagnostics to Feature ColoAlert at the 57th Medizinische Woche Baden-Baden

BERKELEY, Calif. and MAINZ, Germany, Oct. 01, 2024 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQMYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, today released a statement to shareholders highlighting its strategic plans for maximizing shareholder value, clinical developments, and its upcoming FDA trial anticipated for 2025, which aims to pave the way for entry into the U.S. market. Management believes 2025 will be a transformative year, positioning Mainz Biomed for substantial growth in global markets, particularly through its innovative diagnostic solutions.

Strategic Alliance with Former White House Senior Adviser to Focus on Awareness of Mainz Biomed’s Products and the Importance of Early Detection

PancAlert is a Next-Generation Pancreatic Cancer Detection Test in Mainz Biomed’s Research and Development Pipeline – Promising Results of First Analysis

BERKELEY, Calif. and MAINZ, Germany, July 25, 2024 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQMYNZ), a molecular genetics diagnostic company specializing in early detection of cancer, today announced significant improvements to its ColoAlert product, currently being commercialized across Europe and in select international markets. These updates aim to enhance customer satisfaction and streamline lab operations.

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

Industry Leading Clinical Data Position the Company for FDA Premarket Approval Study

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

BERKELEY, Calif. and MAINZ, Germany, May 31, 2024 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQMYNZ), a molecular genetics diagnostic company specializing in the early detection of cancer, held its annual general meeting (“Annual General Meeting”) on Friday, May 31, 2024 in Amsterdam, The Netherlands. Holders of 2,431,947 ordinary shares, representing approximately 10.9% of our outstanding shares on May 3, 2024, the record date for the Annual General Meeting, were present at such meeting, which constituted a quorum under Dutch law. Each of the matters presented at the Annual General Meeting received the requisite shareholder approval as set below:

Key Findings: 92.3% Sensitivity for Colorectal Cancer, 82.3% for Advanced Precancerous Lesions

Mainz Biomed Presented Industry Leading Results: 97% Sensitivity for Colorectal Cancer, 82% for Advanced Precancerous Lesions

The eAArly DETECT results reported a sensitivity for colorectal cancer of 97% with a specificity of 97% and a sensitivity for advanced adenoma of 82%

BERKELEY, Calif. and MAINZ, Germany, April 25, 2024 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQMYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today groundbreaking topline results from a pooled clinical study which included new patients and subjects from Mainz Biomed’s ColoFuture (Europe) and eAArly DETECT (U.S.) clinical trials evaluating the potential to integrate its portfolio of proprietary novel gene expression (mRNA) biomarkers into a next generation version of the Company’s colorectal cancer (CRC) screening tool. The topline results confirm the positive efficacy results previously reported with a sensitivity for colorectal cancer of 92% with a specificity of 90% and a sensitivity for advanced adenoma of 82%, which is best-in-class and compare favorably to existing commercial products.

ColoAlert® Revenue Increased 69% Year Over Year; Net Loss in Line with Previous Year; Cash Balance at Year End of $7.1 Million

BERKELEY, Calif. and MAINZ, Germany, March 19, 2024 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQMYNZ) (“Mainz Biomed” or the “Company”), a leader in molecular genetics diagnostic solutions for early cancer detection, will be organizing the HALLO DOC! event, informing about colorectal cancer, cutting-edge research, new treatment modalities, and holistic therapeutic approaches. This event will take place on March 20, 2024, in Berlin, Germany, aligning with the Colorectal Cancer Awareness Month.

BERKELEY, Calif. and MAINZ, Germany, March 18, 2024 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQMYNZ) (“Mainz Biomed” or the “Company”), a leader in molecular genetics diagnostic solutions for early cancer detection, in collaboration with Ganzimmun, will host an educational webinar on Early Detection of Colorectal Cancer: New Laboratory Diagnostic Options which is taking place on March 20, 2024.

BERKELEY, Calif. and MAINZ, Germany, March 12, 2024 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQMYNZ) (“Mainz Biomed” or the “Company”), a leader in molecular genetics diagnostic solutions for early cancer detection, is proud to announce its upcoming participation at the 39th UDH Congress 2024, taking place on March 16th & 17th in Fellbach, Germany. One of the main focus topics for this year’s event, organized by the German Complementary Medicine Association (Union Deutscher Heilpraktiker, Landesverband Baden-Württemberg), is the gut and its significance in the manifestation of diseases.

BERKELEY, Calif. and MAINZ, Germany, March 05, 2024 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQMYNZ) (“Mainz Biomed” or the “Company”), a leader in molecular genetics diagnostic solutions for early cancer detection, announced today a partnership with Trusted Health Advisors (THA), a market leader in supporting the U.S. launches and management of commercial programs for diagnostic products.

BERKELEY, Calif. and MAINZ, Germany, Feb. 27, 2024 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQMYNZ) (“Mainz Biomed” or the “Company”), a leader in molecular genetics diagnostic solutions for early cancer detection, is proud to announce its participation as an exhibitor at the esteemed Gynecology Congress (‘Gynäkologie und Geburtshilfe aktuell’) in Stuttgart, Germany, on March 1st. This engagement signifies the company's commitment to advancing colorectal cancer (CRC) screening through their innovative diagnostic solution ColoAlert® and highlights the pivotal role of gynecologists in the early detection of this prevalent disease.

BERKELEY, Calif. and MAINZ, Germany, Feb. 22, 2024 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQMYNZ) (“Mainz Biomed” or the “Company”), a leader in molecular genetics diagnostic solutions for early cancer detection, is pleased to announce a distribution partnership with Praxisdienst, Germany’s largest online retailer for medical products. This collaboration, which commenced in February 2024, marks an important step in Mainz Biomed’s mission to enhance healthcare delivery across Germany, focusing on the accessibility of their flagship product, ColoAlert®.

Partnership Brings Pioneering Approach to Incorporating Advanced Colorectal Cancer Detection Into Country’s Healthcare System

Company opens own physician-led laboratory, ‘European Oncology Lab’ (EOL), thereby offering ColoAlert® as a laboratory medical service directly to physicians and patients

BERKELEY, Calif. and MAINZ, Germany, Jan. 11, 2024 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQMYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in early cancer detection, re-affirms its collaboration with TestDNA at the upcoming 10th Gdańsk Gastroenterology Symposium on January 12th–13th, 2024. The companies joined forces to advance innovative colorectal cancer (CRC) detection in Poland and to increase treatment options as well as survival rates through early detection.

BERKELEY, Calif. and MAINZ, Germany, Jan. 09, 2024 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQMYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today a year end summary of its corporate and product development progress.

Hermann Bantleon GmbH (“Bantleon), Shareholder of German AVIA, will Offer the ColoAlert® At-Home Screening Test to Employees Across All Three of Their German Locations, Namely Ulm, Ulm-Nord, and Crimmitschau, in Q1 2024

BERKELEY, Calif. and MAINZ, Germany, Dec. 12, 2023 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQMYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today its active participation alongside Polish partner TestDNA at two significant gastroenterology conferences in Poland, strengthening their commitment to advancing colorectal cancer (CRC) detection and gastroenterological innovation.

BERKELEY, Calif. and MAINZ, Germany, Dec. 05, 2023 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQMYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today groundbreaking topline results from its eAArly DETECT U.S. clinical study, a multi-center feasibility study assessing the potential to integrate a portfolio of novel gene expression (mRNA) biomarkers into a next generation version of ColoAlert®, the Company’s highly efficacious and easy-to-use screening test for colorectal cancer (CRC) being commercialized across Europe and in select international territories. The eAArly DETECT topline results reported a sensitivity for colorectal cancer of 97% with a specificity of 97% and a sensitivity for advanced adenoma of 82%. They confirm the positive results from ColoFuture, its European counterpart which reported data in October 2023.

BERKELEY, Calif. and MAINZ, Germany, Nov. 29, 2023 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQMYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announces that its presentation at the 35th Annual Piper Sandler Healthcare Conference, to be delivered by Chief Executive Officer, Guido Baechler and Bill Caragol, Chief Financial Officer, will be available to view live and post event via webcast by registering at the following link.

BERKELEY, Calif. and MAINZ, Germany, Nov. 20, 2023 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQMYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announces that Guido Baechler, Chief Executive Officer, and Bill Caragol, Chief Financial Officer, will present at the 35th Annual Piper Sandler Healthcare Conference taking place on the 28-30 November, 2023 in New York, NY, USA.

ColoAlert® Revenue Increases 102% Year Over Year for the Nine Months Ended September 30, 2023ColoFuture Study Reported Groundbreaking Results Demonstrating Sensitivity for Colorectal Cancer of 94% with Specificity of 97% and Advanced Adenoma Sensitivity of 80%

BERKELEY, Calif. and MAINZ, Germany, Nov. 15, 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, today announced the closing of its previously announced registered direct offering with several institutional investors to purchase $5.0 million of its ordinary shares (or pre-funded warrants to purchase ordinary shares in lieu thereof) and warrants to purchase ordinary shares. The combined effective purchase price for each ordinary share (or pre-funded warrant) and associated warrant to purchase one ordinary share was $1.20.

BERKELEY, Calif. and MAINZ, Germany, Nov. 13, 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 that it has entered into a securities purchase agreement with several institutional investors to purchase $5.0 million of its ordinary shares (or pre-funded warrants to purchase ordinary shares in lieu thereof) and warrants to purchase ordinary shares in a registered direct offering. The combined effective purchase price for each ordinary share (or pre-funded warrant) and associated warrant to purchase one ordinary share will be $1.20.

Collaboration to utilize cutting-edge AI analysis platform for clinical trials and cancer screening test processing

BERKELEY, Calif. and MAINZ, Germany, Nov. 07, 2023 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQMYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today that VP Commercial Operations, Tarrin Khairi-Taraki, will attend MEDICA by invitation of the Rhineland-Pfalz government.

Almost half of Zöller-KipperGmbH’s employees in Germany participated in the screening program so far using ColoAlert®, Mainz Biomed’s user-friendly, at-home colorectal cancer (CRC) screening test

Former Natera Manager will oversee all aspects of sales and support in EMEA, ensuring the continued commercialization of ColoAlert® across the region

Results indicate a substantial and meaningful enhancement in the effectiveness of non-invasive colorectal cancer (CRC) screening, particularly for the detection of advanced adenomas, a precursor to CRC

Mainz Biomed team members will be available throughout the event at the Company’s booth located in Hall C, Stand C3-92

BERKELEY, Calif. and MAINZ, Germany, Oct. 05, 2023 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQMYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today that Bill Caragol, Chief Financial Officer, will attend the JonesTrading 2023 Healthcare Summit which will take place October 9-11, 2023 in Miami Beach, Florida.

Strategic Collaboration Elevates Early Cancer Detection, Bringing State-of-the-Art Diagnostic Capabilities to Romanian Population

BERKELEY, Calif. and MAINZ, Germany, Sept. 27, 2023 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQMYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today that it will present the positive detailed results from its ColoFuture study at the 4th International Conference on Gastroenterology which occurs on October 16th - 18th in Paris, France. The ColoFuture study was a multi-center international clinical trial assessing the potential to integrate a portfolio of novel gene expression (mRNA) biomarkers into ColoAlert®, the Company’s highly efficacious, and easy-to-use screening test for colorectal cancer (CRC) being commercialized across Europe and in select international territories.

BERKELEY, Calif. and MAINZ, Germany, Sept. 20, 2023 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQMYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today that Guido Baechler, Chief Executive Officer, will present at the Cantor Fitzgerald Global Healthcare Conference which takes place September 26-28, 2023 in New York City.

Multiple novel mRNA biomarkers identified for potential integration into pivotal FDA PMA clinical trial (ReconAAsense)

BERKELEY, Calif. and MAINZ, Germany, Sept. 05, 2023 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQMYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today a strategic partnership with Ärztliches Labor Dr. Buhlmann, a move aimed at further strengthening its position in the German market.

Company Anticipates Read Outs of the Clinical Data from its EU and US Feasibility Studies this September and in Q4

Strategic Partnership Aims to Revolutionize Cancer Screening and Enhance Healthcare Outcomes, Bringing Innovative Genetic Testing Solutions to Individuals Across Poland

ColoAlert® Revenue Increases 108% Year Over Year in the First Six Months of 2023

Collaborative Partnership Strengthens Mainz Biomed's Mission to Combat Colorectal Cancer, Saving Lives through Advanced Diagnostics

Israel has one of the highest screening compliance rates in the world with over one million people being screened each year

Provides option to access capital to support commercial and clinical programs

The Company’s innovative CRC screening test will be showcased at booths 105A and 105B in cooperation with partner lab, Inicio-Instituto de Microecología

ColoAlert® will be offered to an addressable market of 6 million patients through 15 laboratories.

Total addressable market in Poland is estimated at 21 million patients

Employees found the online patient portal, through which they ordered the ColoAlert® test, easy-to-use and convenient

ColoAlert® Revenue Increases 152% Year Over Year

BERKELEY, Calif. and MAINZ, Germany, May 10, 2023 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQMYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today a research collaboration with Microba Life Sciences (ASX: MAP) (“Microba”), a precision microbiome company leveraging a world-leading technology platform for measuring the human gut microbiome to discover and develop novel therapeutics for major diseases. As part of the agreement, Microba and Mainz Biomed will conduct a pilot research project utilizing Microba’s proprietary metagenomic sequencing technology and bioinformatic tools to potentially discover novel microbiome biomarkers for pancreatic cancer detection.

Eurofins GeLaMed to provide test kit processing of ColoAlert® through Germany

Largest international meeting of physicians, researchers, and academics covering gastroenterology, hepatology, endoscopy, and gastrointestinal surgery

BERKELEY, Calif. and MAINZ, Germany, April 27, 2023 (GLOBE NEWSWIRE) -- Mainz Biomed NV (NASDAQMYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announces the following activities in May:

The Instituto de Microecologia to market at-home detection test for colorectal cancer to physicians and their patients

ColoAlert Revenue Increases 130% Year over Year

BERKELEY, Calif. and MAINZ, Germany, April 04, 2023 (GLOBE NEWSWIRE) -- Mainz Biomed NV (NASDAQMYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today that three German-based companies have selected ColoAlert®, the Company’s highly efficacious and easy-to-use screening test for colorectal cancer (CRC) into their respective corporate health programs.

BERKELEY, Calif. and MAINZ, Germany, March 29, 2023 (GLOBE NEWSWIRE) -- Mainz Biomed NV (NASDAQMYNZ) (“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.

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

Sponsor of Gastro Update 2023, 2-day scientific and training events for gastroenterology professionals

BERKELEY, Calif. and MAINZ, Germany, March 21, 2023 (GLOBE NEWSWIRE) -- Mainz Biomed NV (NASDAQMYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced that Bill Caragol, the Company’s CFO, will present and host one-on-one meetings with investors at the Sidoti March Virtual Investor Conference, taking place on March 22-23, 2023.The presentation will begin at 12:15 ET on March 22, 2023 and can be accessed live here:https://sidoti.zoom.us/webinar/register/WN_apzthw9PRlOrUq5PSD5Dcw.Mainz Biomed will also host virtual one-on-ones with investors on Wednesday and Thursday, March 22-23, 2023. To register for the presentation or one-on-ones, visit www.sidoti.com/events. Registration is free and you don't need to be a Sidoti client.About Sidoti & CompanyFor over two decades, Sidoti & Company (http://www.sidoti.com) has been a premier provider of independent securities research focused specifically on small and microcap companies and the institutions that invest in their securities, with most of its coverage in the $100 million-$5 billion market cap range. The firm’s approach affords companies and institutional clients a combination of high-quality research, a small- and microcap-focused nationwide sales effort, broad access to corporate management teams, and extensive trading support. Sidoti serves 500+ institutional clients in North America.About ColoAlert ColoAlert, Mainz Biomed’s flagship product, delivers high sensitivity and specificity in a user-friendly, at-home colorectal cancer (CRC) screening kit. This non-invasive test can be indicative of tumors as determined by analyzing tumor DNA, offering better early detection than fecal occult blood tests (FOBT). Based on PCR-technology, ColoAlert detects more cases of colorectal cancer than other stool tests and allows for an earlier diagnosis (Gies et al., 2018). The product is commercially available in select EU countries through a network of leading independent laboratories, corporate health programs, and via direct sales. To receive marketing approval in the US, ColoAlert will be evaluated in the FDA-registration trial ‘ReconAAsense’. 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. About Colorectal Cancer Colorectal cancer (CRC) is the third most common cancer globally, with more than 1.9 million new cases reported in 2020, according to World Cancer Research Fund International. The US Preventive Services Task Force recommends that screening with stool DNA tests such as ColoAlert should be conducted once every three years starting at age 45. Each year in the US, 16.6 million colonoscopies are performed. However, roughly one-third of US residents aged 50-75 have never been screened for colon cancer. This gap in screening represents a $4.0B+ total market opportunity in the US. 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 based on real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in stool samples. ColoAlert is currently marketed across Europe. The Company is 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. To learn more, visit mainzbiomed.com or follow us on LinkedIn, Twitter and Facebook.  For media inquiries, please contact press@mainzbiomed.com

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.