Former Roche executive Amy Levin, RAC, brings more than 20 years of regulatory affairs experience as an in vitro diagnostics (IVD) industry leader
BERKELEY, US – MAINZ, Germany – November 29, 2022 — Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today the appointment of Amy Levin, RAC, as Vice President of Regulatory Affairs.
In this role, Ms. Levin will be in charge of guiding the implementation and regulatory, clinical trial and quality initiatives that are related to in vitro diagnostics. She will contribute to key milestones for the FDA submission process for ColoAlert, the Company’s highly efficacious and easy-to-use DNA-based detection test for colorectal cancer (CRC). She will also be responsible for bridging the gap between business development and regulatory, clinical trial and quality teams to ensure the implementation of programs adhere to all regulatory specifications and meet customer expectations and goals.
“Ms. Levin is an outstanding addition to our executive team and is well known as a strategic thinker, methodical problem solver and inclusive people manager who is results-oriented,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “With these strong attributes and extensive professional experience, she will help drive our internal processes to support operational excellence as we execute our clinical trials and work toward FDA submission and approvals in the U.S.”
Ms. Levin has a successful track record of leading and collaborating with cross-functional teams and regulatory authorities to author, manage and review required reports of the U.S. Food and Drug Administration (FDA) and international regulatory submissions. Previously, she worked as Director, Roche Molecular Diagnostics (RMD) International Regulatory Affairs at RMD after serving in many roles with increasing leadership responsibilities within the company. While there, Ms. Levin drove the development and implementation of regulatory strategies for introducing new products in the marketplace and negotiated with worldwide health authorities to enable expeditious approval and importation of products across more than 50 countries. She has also held other regulatory positions at multiple Biotechnology companies in the San Francisco Bay area.
“I have spent a majority of my career in regulatory affairs and am excited to use my expertise and in-depth knowledge of the regulatory guidelines, landscape and processes to further advance ColoAlert with a focus on the U.S. as its key market as well as the Company’s portfolio of cancer detection products,” said Ms. Levin.
ColoAlert detects colorectal cancer (CRC) via a simple-to-administer test with a sensitivity and specificity nearly as high as the invasive colonoscopy (Dollinger MM et al., 2018). The test utilizes proprietary methods to analyze cell DNA for specific tumor markers combined with the fecal immunochemical test (FIT) and is designed to detect tumor DNA and CRC cases in their earliest stages. The product is CE-IVDR marked (complying with EU safety, health and environmental requirements) and commercially available in a selection of countries in the European Union and the United Arab Emirates. Mainz Biomed currently distributes ColoAlert through a number of clinical affiliates. 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 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. ColoAlert is currently marketed across Europe and the United Arab Emirates with the intention of beginning its pivotal FDA clinical study in 2022 for US regulatory approval. Mainz Biomed’s product candidate portfolio also 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. 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.