Mainz Biomed and Dante Genomics Announce Full Commercial Availability of ColoAlert in Italy and the United Arab Emirates
16 August 2022 - 5:01PM
Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz'' or the “Company”), a
molecular genetics diagnostic company specializing in the early
detection of cancer, and Dante Genomics, a global leader in
genomics and precision medicine, announced today the formal
commencement of ColoAlert’s consumer commercial program in Italy
and the United Arab Emirates (UAE). ColoAlert is Mainz’s flagship
product, a highly efficacious and easy to use, at-home detection
test for colorectal cancer (CRC) currently being commercialized
across Europe and select international markets. With the ColoAlert
test CE-IVD certified and patient collection kit CE marked to the
latest IVDR requirements, ColoAlert will now be marketed through
Dante’s extensive database and sold via Dante’s, region-specific,
ecommerce websites.
“This is an important milestone for the company as it expands
our global footprint while providing access to those who can
benefit from our cutting-edge early detection CRC test in these
additional major international territories,” commented Guido
Baechler, Chief Executive Officer of Mainz Biomed. “Dante has been
an exceptional partner, and we look forward to continue working
closely with them as they actively market and sell ColoAlert and
also as they transition from processing samples at Mainz’s in-house
facility, to their own wholly-owned automated genomic sequencing
laboratories in Italy (Europe) and Dubai (UAE) where they’ll offer
localized service and support.”
Dante Genomics is a global leader in whole genome sequencing and
holds an existing database of tens of thousands of whole genomes.
The company has a product development and commercial franchise
focused on providing personalized preventive healthcare solutions.
It achieves this by leveraging its robust databases and proprietary
software platform to offer next-generation diagnostic tools direct
to consumers and healthcare professionals.
“From our perspective, ColoAlert represents the first true step
toward personalized medicine in colorectal cancer, and we are
excited to leverage our expertise in genomic data to partner with
Mainz in commercializing this important diagnostic tool,” said
Andrea Riposati, Chief Executive Officer of Dante Genomics.
“Through our partnership with Mainz, we will drive more informed
healthcare decisions and empower patients with their genomic
data.”
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 immunochemical 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 estimated that in 2021 there were
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
About Dante Genomics
Dante Genomics is a global genomic information
company building and commercializing a new class of transformative
health and longevity applications based on whole genome sequencing
and AI. The Company uses its platform to deliver better patient
outcomes from diagnostics to therapeutics with assets including one
of the largest private genome databases with research consent,
proprietary software designed to unleash the power of genomic data
at scale and proprietary processes which enable an industrial
approach to genomic sequencing.
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 as well
as the Prospectus filed on January 21, 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.
Dante Genomics Contact:Laura D’AngeloVP of
Investor Relationsir@dantelabs.com+39 0862 191
0671www.dantegenomics.com
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