Mainz Biomed Appoints Amy Levin as Vice President of Regulatory Affairs to Oversee Global Regulatory Strategies
November 29 2022 - 8:00AM
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.
About ColoAlertColoAlert 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 NVMainz 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.
For media inquiries, please
contact press@mainzbiomed.comIn
Europe:
MC Services AGAnne Hennecke/Caroline Bergmann+49 211 529252
20mainzbiomed@mc-services.eu
In the US:
Spectrum ScienceMelissa Laverty/Valerie Enes+1 540 272
6465mainz@spectrumscience.com
For investor inquiries, please
contact ir@mainzbiomed.com
Forward-Looking StatementsCertain 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.
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