Mainz Biomed Launches Enhanced ColoAlert with Cutting-Edge Features to Optimize Screening Efficiency and User Convenience
25 Luglio 2024 - 2:01PM
Mainz Biomed N.V. (NASDAQ: MYNZ), a molecular genetics diagnostic
company specializing in early detection of cancer, today announced
significant improvements to its ColoAlert product, currently being
commercialized across Europe and in select international markets.
These updates aim to enhance customer satisfaction and streamline
lab operations.
ColoAlert is a highly efficacious and easy-to-use,
at-home detection test for colorectal cancer (CRC). The test
utilizes proprietary methods to analyze cell DNA for specific tumor
markers combined with the fecal immunochemical test (FIT). It is
designed to detect tumor DNA and CRC cases in their earliest
stages.
To increase screening/lab efficiency, Mainz Biomed
has introduced a novel DNA stabilizing buffer capable of
accommodating varying sample volumes. This breakthrough addresses a
common issue in the industry where samples are often either
underfilled or overfilled, rendering them unsuitable for laboratory
analysis. Consequently, patients frequently have to repeat their
screening test. The new proprietary buffer used in ColoAlert
significantly reduces the necessity for additional sample
submissions, thereby reducing the time for the patients to obtain
their results. This enhancement has enabled ColoAlert to achieve
the industry's lowest retesting rates, ensuring that screening
outcomes are delivered within just 2 - 3 days upon arrival at the
laboratory.
Furthermore, Mainz Biomed has refined the ColoAlert
kit for improved usability, including a variety of new features,
such as an improved collection device, a new tube and tube holder,
etc. These upgrades streamline the sample collection process,
offering users a more straightforward and reliable experience.
"Our commitment to preserving DNA samples and
optimizing testing procedures underscores our dedication to
delivering superior colorectal cancer screening while ensuring
convenience for patients," stated Tarrin Khairi-Taraki, VP
Commercial Operations at Mainz Biomed.
The updated ColoAlert product is now accessible to
existing laboratory partners and readily available to prospective
collaborators.
Please visit Mainz Biomed’s official
website for investors at mainzbiomed.com/investors/ for more
information
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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 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
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
planning to run 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.
For media inquiries
MC Services AGAnne Hennecke/Caroline Bergmann+49
211 529252 20mainzbiomed@mc-services.eu
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
April 9, 2024. 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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