Laboratory Stein is part of the Limbach Group, which is the largest network of laboratories in Germany and one of the largest networks of laboratories in Europe.
Laboratory MVZ Dr. Stein + Kollegen processes over five million samples annually with a team of 500 employees that includes biologists, chemists, doctors and other specialists.
BERKELEY, US – MAINZ, Germany – FEBRUARY 14th, 2022 — 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 a partnership with Labor MVZ Dr. Stein + Kollegen (“Laboratory Mönchengladbach”). Laboratory Mönchengladbach, one of the largest diagnostics laboratories in the North Rhine-Westphalia region of Germany, will commercialize ColoAlert, Mainz Biomed’s unique, highly efficacious, and easy-to-use detection test for colorectal cancer (CRC).
With a team of over 500 employees that includes biologists, chemists, doctors and other specialists, Laboratory Mönchengladbach services over 2500 physicians, processing over five million samples in total annually and screening approximately 1000 patients per week specifically for CRC.
“As a result of our unique model of engaging in mutually beneficial commercial partnerships with leading laboratories such as MVZ Dr. Stein + Kollegen, Mönchengladbach, we’re able to quickly and effectively expand our national footprint and enable larger populations to benefit from highly efficient and reliable CRC testing,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “We are ideally positioned to further scale operations across Europe and will continue to pursue and engage in beneficial partnerships with the leading diagnostics labs in each jurisdiction being targeted.”
Under the terms of the partnership, Mainz Biomed will co-brand ColoAlert with Laboratory Mönchengladbach, and sell its polymerase chain reaction (PCR) assay kits for advanced colorectal cancer detection, on an on-demand basis for use by Labor Mönchengladbach’s network of physicians and their patients. In order to optimize awareness and adoption, Mainz Biomed and Labor Mönchengladbach will also collaborate to deliver a comprehensive marketing and education campaign to include direct-to-consumer advertising, cross channel promotion to physician networks, webinars and sales representative training.
“As an organization focused on delivering the very best diagnostics solutions to our network, we’ve been highly impressed by the efficacy of the ColoAlert test. We’re thrilled to be able to make it available to patients via their physicians across the region and catch more cases of this deadly disease in its earliest stages where it can be successfully treated,” said Dr. Dietmar Dreßen, Managing Director, Laboratory Mönchengladbach.
ColoAlert detects colorectal cancer (CRC) via a simple-to-administer test with a sensitivity and specificity nearly as high as the invasive colonoscopy*. The test utilizes proprietary methods to analyze cell DNA for specific tumor markers combined with the fecal immunochemistry test (FIT) and is designed to detect tumor DNA and CRC cases in their earliest stages. The product is CE-IVD marked (complying with EU safety, health and environmental requirements) and is transitioning to compliance with IVDR. The product is commercially available in a selection of countries in the Europe Union. Mainz Biomed currently distributes ColoAlert through a number of clinical affiliates. Once approved in the U.S., 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 second most lethal cancer in the U.S. and Europe, but also the most preventable with early detection providing survival rates above 90%. Annual testing costs per patient are minimal, especially when compared to late-stage treatments of CRC which cost patients an average of $38,469 per year. The American Cancer Society estimates that in 2021 there will be approximately 149,500 new cases of colon and rectal cancer in the U.S. with 52,980 resulting in death. Recent FDA decisions suggest that screening with stool DNA tests such as ColoAlert in the US should be conducted once every three years starting at age 45. Currently there are 112 million Americans aged 50+, a total that is expected to increase to 157 million within 10 years. Appropriately testing these US-based 50+ populations every three years as prescribed equates to a US market opportunity of approximately $3.7 Billion per year.
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. ColoAlert is currently marketed across Europe with FDA clinical study and submission process intended to be launched in the first half of 2022 for U.S. regulatory approval. Mainz Biomed’s product candidate portfolio includes PancAlert, an early-stage pancreatic cancer screening test based on Real-Time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in stool samples, and the GenoStick technology, a platform being developed to detect pathogens on a molecular genetic basis.
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 Prospectus filed on October 12, 2021 and amended on October 25, 2021 and November 1, 2021 as well as the Prospectus filed on January 21, 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.