BERKELEY, Calif. and MAINZ, Germany, July 25, 2024 (GLOBE NEWSWIRE) — Mainz Biomed N.V. (NASDAQ: MYNZ), 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.
ColoAlert is a highly efficacious and easy-to-use, at-home detection test for colorectal cancer (CRC). 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.
To increase screening/lab efficiency, Mainz Biomed has introduced a novel DNA stabilizing buffer capable of accommodating varying sample volumes. This breakthrough addresses a common issue in the industry where samples are often either underfilled or overfilled, rendering them unsuitable for laboratory analysis. Consequently, patients frequently have to repeat their screening test. The new proprietary buffer used in ColoAlert significantly reduces the necessity for additional sample submissions, thereby reducing the time for the patients to obtain their results. This enhancement has enabled ColoAlert to achieve the industry’s lowest retesting rates, ensuring that screening outcomes are delivered within just 2 – 3 days upon arrival at the laboratory.
Furthermore, Mainz Biomed has refined the ColoAlert kit for improved usability, including a variety of new features, such as an improved collection device, a new tube and tube holder, etc. These upgrades streamline the sample collection process, offering users a more straightforward and reliable experience.
“Our commitment to preserving DNA samples and optimizing testing procedures underscores our dedication to delivering superior colorectal cancer screening while ensuring convenience for patients,” stated Tarrin Khairi-Taraki, VP Commercial Operations at Mainz Biomed.
The updated ColoAlert product is now accessible to existing laboratory partners and readily available to prospective collaborators.
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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 planning to run 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 9, 2024. 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.
