BERKELEY, Calif. and MAINZ, Germany, Nov. 30, 2021 — Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostics company specializing in the early detection of cancer, announced today the Company has engaged Precision for Medicine, a leading global Clinical Research Organization, to provide U.S. regulatory and reimbursement advisory support for ColoAlert, Mainz’s highly efficacious and easy-to-use diagnostic test for colorectal cancer.
“As an emerging commercial stage company with a portfolio of non-invasive, highly efficacious diagnostics for detection of early-stage cancer indications in development, we are mindful of the need to operate a streamlined corporate and clinical organization,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “I’m extremely pleased to partner with Precision for Medicine as they provide premier and comprehensive solutions that can help ensure ColoAlert is well positioned to achieve FDA regulatory approval, and acceptance by the Centers for Medicare and Medicaid (CMS) for reimbursement, which is of course, essential for gaining commercial traction.”
Precision for Medicine will work with Mainz’s management team to develop and implement a U.S. focused regulatory and market access strategy for ColoAlert, the Company’s unique, life-saving early detection test for colorectal cancer (CRC). This will include assistance in drafting ColoAlert’s clinical development plan to ensure the trial design is cost-effective, robust, and efficient. Inherent to this exercise will be the integration of CMS guidelines, utilizing currently marketed CRC screening tests as benchmarks to provide ColoAlert with an optimal product profile for regulatory approval and success in the marketplace. Along the way, Precision for Medicine will advise Mainz throughout its interaction with the FDA’s pre-submission protocol.
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 European 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.
*Dollinger MM et al. (2018)
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.
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About Precision for Medicine
Precision for Medicine is the first biomarker-driven clinical research services organization supporting life sciences companies in the use of biomarkers essential to targeting patient treatments more precisely and effectively. Precision applies novel biomarker approaches to clinical research that integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. This convergence of trials, labs and data sciences is driving faster clinical development and approval. Precision for Medicine is part of Precision Medicine group with over 2,500 people in 40 locations in the U.S., Canada, and Europe. For more information, visit https://www.precisionformedicine.com.
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. 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.