BERKELEY, Calif. and MAINZ, Germany, Dec. 19, 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 second phase of its colorectal cancer (CRC) screening campaign through its BGM (“betriebliches Gesundheitsmanagement”) partnership with Bantleon, a shareholder of German AVIA and renowned for its high-performance lubricants and service solutions. Bantleon selected ColoAlert®, Mainz Biomed’s highly efficacious and easy-to-use screening test for CRC, for its corporate health program (BGM).
This continued BGM initiative follows a successful pilot program and will launch in Q1 2024 in line with CRC awareness month March. Via the Company’s BGM program, Bantleon offers ColoAlert® to its employees across all three sites in Germany – Ulm, Ulm-Nord and Crimmitschau. Bantleon employees are able to register using Mainz Biomed’s online portal and have the ColoAlert® test mailed to them. Once the sample is received and processed, confidential test results are returned to the employee through the portal, along with an explanation of the results. Employees can also approve for their physician to be notified of the test results in which case, their doctor can directly follow-up with them. As part of its commitment to the BGM program, Mainz Biomed provides education to employees and physicians on CRC and recommendations for next steps.
Rainer Janz, Head of Product and Quality Management at Bantleon, expressed enthusiasm about the ongoing collaboration, stating, “At Bantleon, we are committed to prioritizing the health and wellbeing of our employees. The feedback we received from our associates throughout the first phase of our CRC screening campaign was entirely positive. Mainz Biomed made it easy for us to implement the test in our BGM program and not only provided a convenient procedure for all participants but also fast and reliable results. We are looking forward to expanding our collaboration by offering ColoAlert® to our team members in a second CRC screening round.”
Darin Leigh, Chief Commercial Officer at Mainz Biomed, added: “Early detection is key to increasing treatment options as well as survival rates for colorectal cancer patients. Screening at regular intervals is essential to detecting the disease in early stages where it can be successfully treated and dramatically improve patient outcomes. We applaud Bantleon for their highly progressive approach to the wellbeing of their employees and look forward to our continued collaboration as we work to spare more people from the devastating impacts of this disease.”
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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 (Dollinger 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 N.V.
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.
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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 7, 2023. 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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