Mainz BioMed Appoints Karen Richards as Vice President, Regulatory Affairs to Lead US FDA Approval Process
BERKELEY, Calif. and MAINZ, Germany, Dec. 21, 2021 (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 appointment of Karen Richards as its Vice President of Regulatory Affairs.
“It is a pleasure to welcome Karen to the management team, and her appointment is particularly important as she brings specific expertise in shepherding diagnostic products through the U.S. regulatory process,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “Karen joins us at a pivotal time in our growth, as we ramp-up the commercialization of ColoAlert across Europe and prepare to formally embark on the U.S. regulatory approval pathway.”
Ms. Richards is a proven leader and innovator in the in vitro diagnostics (IVD) industry. With a career spanning over 30 years, she often spearheaded regulatory approvals worldwide for both novel and traditional IVD assays and products, as well as laboratory developed tests in the United States. In her concurrent role as Senior Vice President, In Vitro Diagnostics and Quality at Precision for Medicine, she leads the IVD regulatory and quality consulting team, helping companies achieve market entry using multiple technologies including but not limited to PCR and RT-PCR, next-gen sequencing, immunoassays, IHC, flow cytometry and liquid biopsy, targeting diagnostics and companion diagnostics for gene therapy, infectious disease, oncology, colorectal cancer, and other disease modalities. She has also been responsible for approval of laboratory tests in all U.S. states requiring a license, including New York State. She has implemented from the ground-up quality systems for diagnostic products to meet the requirements of US FDA, ISO 9001, ISO 13485, CLIA, and CAP. She has also developed and implemented clinical trials for multiple products that were used to generate data for regulatory submissions. Ms. Richards has served as the Compliance Officer for three companies, covering both traditional diagnostic products as well as clinical laboratory tests, and has served as a board member to the Association of Medical Diagnostics Manufacturers (AMDM) during various terms since 2003.
“I’m excited to join Mainz as it provides me with the opportunity to play an integral role in bringing to the U.S. market a unique test for this deadly form of cancer,” commented Karen Richards, Vice President of Regulatory Affairs of Mainz BioMed. “It is widely known that early detection for colorectal cancer is essential in achieving patient survival, and I’m looking forward to working with the Mainz team to facilitate the approval process for ColoAlert in the U.S. to provide a top-tier discretionary testing solution.”
About ColoAlert
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.
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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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 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.
