Mainz Biomed Engages DCN Dx to Support Clinical Study Evaluating Novel mRNA Biomarkers for Potential Integration into ColoAlert
January 19 2022 - 3:01AM
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 it has formally contracted
with DCN Dx, a leading international developer of point-of-care
diagnostics, and provider of comprehensive product development
services. An integral part of the engagement will be the role of
Emily Friedland, Vice President of Clinical Research at DCN Dx, who
will spearhead the preparation and initiation of Mainz’s European
centric clinical study to evaluate the potential to integrate a
portfolio of recently acquired novel mRNA biomarkers into
ColoAlert, the Company’s highly efficacious, and easy-to-use
detection test for colorectal cancer. This suite of biomarkers
which were in-licensed from Socpra Sciences Santé Et Humaines
S.E.C. (“TTS”) in early January 2022, have demonstrated the unique
ability to detect pre-cancerous lesions including advanced adenomas
(AA), a type of pre-cancerous polyp often attributed to colorectal
cancer (CRC). The study is on track to commence in the first half
of 2022.
“We are excited to work with the DCN Dx team and in particular,
Emily Friedland who brings tremendous expertise in designing and
managing clinical trials for molecular genetic diagnostic tests in
development,” commented Guido Baechler, Chief Executive Officer of
Mainz Biomed. “If this study proves statistically significant, it
will position ColoAlert as the most comprehensive and accurate CRC
self-administered screening test on the market, as its enhanced
technical profile will detect cancerous polyps with a high degree
of accuracy and potentially eliminate CRC via its ability to detect
lesions associated with contracting this deadly disease.”
Under the terms of the engagement, DCN Dx will be responsible
for the selection of additional clinical research organizations
(CRO) and assist Mainz’s management with the development of robust
study protocols and associated clinical processes. Emily brings to
the project over 20 years of clinical research experience as a
scientist and executive. She spent over a decade at Roche Molecular
Systems focused on clinical studies for regulatory approval of
PCR-based molecular devices, primarily in infectious diseases and
STDs. Prior to joining DCN Dx, Emily served as the Director of
Global Clinical Operations for Teleflex, Inc., a manufacturer of
traditional medical devices where her team was responsible for all
sponsored and investigator-initiated research across Teleflex’s
five business units including Clinical Operations, Biostatistics
and Data Management. Emily holds a BS in Biology (concentration in
Microbiology) from Virginia Tech.
Mainz is currently marketing ColoAlert across Europe through its
unique business model of partnering with third-party laboratories
for test kit processing versus the traditional methodology of
operating a single facility. The Company is also preparing to
initiate ColoAlert’s regulatory pathway for approval in the U.S.,
and results from the European biomarker study will potentially be
incorporated into the design of the U.S. clinical study.
About ColoAlertColoAlert 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 CancerColorectal 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 DCN DxDCN Dx's globally-recognized
products and services enable today's leading rapid diagnostics
tests. DCN Dx provides end-to-end support for rapid diagnostic
test development and production in an array of applications. With
DCN Dx, clients receive the products and development, design,
manufacturing, and commercialization expertise they need to meet
their rapid diagnostic milestones. Learn more at dcndx.com
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.
For more information, please visit
www.mainzbiomed.com
For media enquiries, please contact
press@mainzbiomed.com
For investor enquiries, 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 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.
Mainz BioMed NV (NASDAQ:MYNZ)
Historical Stock Chart
From Mar 2024 to Apr 2024
Mainz BioMed NV (NASDAQ:MYNZ)
Historical Stock Chart
From Apr 2023 to Apr 2024