Issuer: Mainz BioMed N.V.
/ Key word(s): Miscellaneous
15.03.2023 / 08:01 CET/CEST
The issuer is solely responsible for the content of this announcement.
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, US – MAINZ, Germany – [March 15, 2023] — 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.”
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.
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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 www.sec.gov. 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.
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