Mainz Biomed Expands Commercial Footprint into Poland
May 31 2023 - 2:01AM
Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a
molecular genetics diagnostic company specializing in the early
detection of cancer, announced today the establishment of a
commercial partnership for ColoAlert® with TESTDNA Sp. z o.o. Sp.
k. Katowice, Poland, a leading independent laboratory in Poland.
ColoAlert is Mainz Biomed’s flagship product, a highly efficacious
and easy to use, at-home detection test for colorectal cancer (CRC)
currently being commercialized across Europe and in select
international markets via a differentiated business model of
partnering with third-party laboratories for test kit processing
versus the traditional methodology of operating a single facility.
“Entering the Polish market is an important milestone for the
Company and we are thrilled by the opportunity to partner with
TESTDNA to establish ColoAlert’s commercial footprint in this
territory,” commented Darin Leigh, Chief Commercial Officer of
Mainz Biomed. “TESTDNA is an exciting addition to our growing
network of international laboratory partners who are committed to
providing cutting-edge diagnostic screening tools to improve
patient survival and disease prevention from deadly indications
such as CRC, the second most lethal cancer in Europe.”
According to Digestive Cancers Europe, Poland shows a
particularly high need for reliable non-invasive screening methods,
with only about one in five patients willing to use colonoscopy for
screening. The incidence of 19,000 new cases annually with
approximately 12,000 colorectal cancer-related deaths confirms the
need for at-home screening tests with good early stage detection.
The addressable market in Poland is estimated at 21 million
patients.
Mainz Biomed is providing ColoAlert to TESTDNA under the
standard terms of the Company’s partnership agreements. In the
coming weeks, Mainz Biomed will work with TESTDNA to prepare and
launch co-marketing activities to ensure successful
commercialization in the Polish market.
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 CancerColorectal 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 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 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.com In
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 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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