Mainz Biomed Announces Partnership with Labor Staber to Expand ColoAlert Commercialization in Germany
March 15 2023 - 3:01AM
Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a
molecular genetics diagnostic company specializing in the early
detection of cancer, announced today a partnership with Dr Staber
& Kollegen GmbH (Labor Staber) as part of its growing network
of laboratories offering ColoAlert, its flagship product that is a
highly efficacious and easy-to-use at-home screening test for
colorectal cancer (CRC). For more than 35 years, Labor Staber has
been providing physicians and hospitals with medical laboratory
services at nine locations across Germany.
“At Mainz, we are on a mission to save lives through the early
detection of CRC – the third most common cancer globally – by
increasing consumer access to affordable and reliable CRC screening
tests like ColoAlert,” said Guido Baechler, Chief Executive Officer
of Mainz Biomed. “We continue to build mutually beneficial
partnerships with diagnostic labs such as Labor Staber, as we have
found putting our PCR testing kits in the hands of highly
professional laboratory networks to be a much more effective
business model than the traditional methodology of operating
testing at a single facility.”
With more than 800 employees, including almost 100 medical
specialists, biologists, chemists, and other academics from a wide
variety of disciplines, Labor Staber offers a broad range of
state-of-the-art medical diagnostics and services from a single
source. Under the terms of this agreement, ColoAlert will now be
marketed through Labor Staber’s extensive network of physicians and
laboratories.
“Our labs combine regional character and collegiality with the
organizational competence of a Germany-wide active laboratory
group,” said Dr. Thomas Kellerer, Head of Molecular Biology at
Labor Staber. “We look forward to working with Mainz as we share
the same passion – to improve patients’ lives by using the most
advanced analysis methods and equipment, as well as the highest
quality standards, in all of our medical diagnostics.”
About ColoAlert ColoAlert, Mainz Biomed’s
flagship product, delivers high sensitivity and specificity in a
user-friendly, at-home colorectal cancer (CRC) screening kit. This
non-invasive test can be indicative of tumors as determined by
analyzing tumor DNA, offering better early detection than fecal
occult blood tests (FOBT). Based on PCR-technology, ColoAlert
detects more cases of colorectal cancer than other stool tests and
allows for an earlier diagnosis (Gies et al., 2018). The product is
commercially available in select EU countries through a network of
leading independent laboratories, corporate health programs and via
direct sales. To receive marketing approval in the US, ColoAlert
will be evaluated in the FDA-registration trial ‘ReconAAsense’.
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 Colorectal Cancer Colorectal cancer
(CRC) is the third most common cancer globally, with more than 1.9
million new cases reported in 2020, according to World Cancer
Research Fund International. The US Preventive Services Task Force
recommends that screening with stool DNA tests such as ColoAlert
should be conducted once every three years starting at age 45. Each
year in the US, 16.6 million colonoscopies are performed. However,
roughly one-third of US residents aged 50-75 have never been
screened for colon cancer. This gap in screening represents a
$4.0B+ total market opportunity in the US.
About Mainz Biomed NV 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 based on
real-time Polymerase Chain Reaction-based (PCR) multiplex detection
of molecular-genetic biomarkers in stool samples. ColoAlert is
currently marketed across Europe. The Company is running a pivotal
FDA clinical study for US regulatory approval. Mainz Biomed’s
product candidate portfolio also includes PancAlert, an early-stage
pancreatic cancer screening test. 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
info@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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