Mainz Biomed Expands ColoAlert Commercialization with GANZIMMUN Diagnostics in Europe
December 14 2021 - 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 a partnership with leading
diagnostics laboratory GANZIMMUN Diagnostics AG (GD), one of
Europe's leading laboratories for preventive and complementary
medicine, for the commercialization in Germany of ColoAlert,
Mainz’s unique, highly efficacious, and easy-to-use detection test
for colorectal cancer.
Under the terms of the arrangement, Mainz will co-brand
ColoAlert with GD, one of the largest stool analysis labs in
Germany. GD will purchase Mainz’s customized polymerase chain
reaction (PCR) assay kits to deliver its large network of
physicians and their patients a comprehensive solution for advanced
colorectal cancer prevention. These kits will be provided to GD on
an on-demand basis and further expand coverage especially in Mainz,
Wiesbaden and Frankfurt.
“This is an important milestone for the company as we embark on
executing a differentiated business model for ColoAlert from other
at-home testing providers,” commented Guido Baechler, Chief
Executive Officer of Mainz Biomed. “As we launch ColoAlert across
Europe, we are steadfast in executing our strategy to establish
commercial partnerships with leading third-party laboratories to
provide customers with the most efficient and reliable test
results. I’m particularly pleased to have GANZIMMUN serve as one of
our inaugural partners given its well-documented role serving as a
premier laboratory.”
GD has an interdisciplinary team of over 370 medical technical
assistants, physicians, chemists, biologists, and nutritionists who
process approximately 5,500 laboratory orders daily. The Company,
which was founded in 1998, is based in Mainz, Rhineland-Palatinate,
Germany and offers a state-of-the art facility with certified
medical training available online and on-site.
“On behalf of the entire GANZIMMUN team, I’m excited by the
addition of ColoAlert to our suite of products,” commented Dr.
Patrik Zickgraf, Chief Executive Officer of GD. “We pride ourselves
on offering and representing cutting-edge diagnostic technologies,
and view ColoAlert as a unique solution to implement next
generation PCR-based testing for colorectal cancer, a deadly
disease where early detection dramatically increases the chance of
survival.”
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 Europe 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 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.
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 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.
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