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 …

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