MYNZ MAINZ BIOMED BV

Mainz Biomed Expands Corporate Health Program for ColoAlert with the Addition of Three New Companies in Germany

Mainz Biomed Expands Corporate Health Program for ColoAlert with the Addition of Three New Companies in Germany

BERKELEY, Calif. and MAINZ, Germany, April 04, 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 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.

“At Mainz Biomed, we believe that everyone should have access to colorectal cancer screening, since almost 73,000 cases of colorectal cancer are diagnosed annually in Germany,” said Guido Baechler, Chief Executive Officer of Mainz Biomed. “Including ColoAlert in corporate health programs provides an easy way for employees to get the testing they need. Early CRC detection and diagnosis enables employees to receive better treatment options that may lead to improved outcomes. We look forward to working with these three new companies and applaud their commitment to making employee health an integral part of their culture.”

Mainz Biomed offers an online portal through which employees can register to be sent the ColoAlert® test. Once the sample is received and processed, confidential test results are sent back to the employee through the portal, along with an explanation of the results. If an employee has approved for their physician to be notified of test results, then the doctor may directly follow-up with the patient. As part of its commitment to the BGM program, Mainz Biomed provides education to employees and physicians on CRC and recommendations for next steps.

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 (). 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  or follow us on ,  and .

For media inquiries, please contact

In Europe:

MC Services AG

Anne Hennecke/Caroline Bergmann

20

In the US:

Spectrum Science

Melissa Laverty/Valerie Enes



For investor inquiries, please contact

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 May 5, 2022. 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.



EN
04/04/2023

Underlying

To request access to management, click here to engage with our
partner Phoenix-IR's CorporateAccessNetwork.com

Reports on MAINZ BIOMED BV

 PRESS RELEASE

Mainz Biomed Receives Swiss Regulatory Approval to Market ColoAlert®

Mainz Biomed Receives Swiss Regulatory Approval to Market ColoAlert® BERKELEY, Calif. and MAINZ, Germany, Aug. 13, 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, announces today that ColoAlert®, its non-invasive colorectal cancer (CRC) screening test, has been officially registered and approved for distribution by Swissmedic, the Swiss regulatory and supervisory authority for medicinal products and medical devices. In Switzerland, CRC screening programs pr...

 PRESS RELEASE

Mainz Biomed Announces Pricing of $3.0 Million Follow-On Offering of O...

Mainz Biomed Announces Pricing of $3.0 Million Follow-On Offering of Ordinary Shares and Warrants BERKELEY, Calif. and MAINZ, Germany, Aug. 04, 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, today announced the pricing of a follow-on offering of 2,222,222 units, with each unit consisting of one ordinary share (or pre-funded warrant in lieu thereof) and one Series A warrant to purchase one and one half ordinary shares for gross proceeds of approximately $3.0 m...

 PRESS RELEASE

Mainz Biomed and CARE Conclude Cooperation Agreement for Joint Care Co...

Mainz Biomed and CARE Conclude Cooperation Agreement for Joint Care Concept for Health Insurance Companies CARE currently cooperates with 19 health insurance companies in Germany in the field of colorectal cancer screening BERKELEY, Calif. and MAINZ, Germany, July 23, 2025 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company“), a diagnostics company specializing in the early detection of cancer, today announced a collaboration with CARE diagnostica Laborreagenzien GmbH (“CARE”). CARE is currently working with more than 15 statutory health insurance ...

 PRESS RELEASE

Mainz Biomed Half Year 2025 Update: Accelerating FDA Pathway for NextG...

Mainz Biomed Half Year 2025 Update: Accelerating FDA Pathway for NextGen Colorectal Cancer Screening and Expansion with Pancreatic Cancer Screening Acquisition Company Advances its Progress toward FDA Premarket Approval Study for its Next Generation Colorectal Cancer Screening Product and Makes a Strategic Acquisition in the Field of Pancreatic Cancer Screening BERKELEY, Calif. and MAINZ, Germany, July 15, 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, toda...

 PRESS RELEASE

Mainz Biomed Secures Public Funding to Advance Innovative Pancreatic C...

Mainz Biomed Secures Public Funding to Advance Innovative Pancreatic Cancer Screening Test BERKELEY, Calif. and MAINZ, Germany, June 25, 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 pleased to announce that its pancreatic cancer project will receive public funding from the Investitions- und Strukturbank Rheinland-Pfalz (ISB), the development bank of the German federal state of Rheinland-Pfalz. Under the ISB’s Innovation and Technology Support Program ...

ResearchPool Subscriptions

Get the most out of your insights

Get in touch