Mainz Biomed & Dante Labs Announce Partnership for the Commercialization of ColoAlert in Europe and the United Arab Emirates (UAE)
May 19 2022 - 3:01AM
Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz” or the “Company”), a
molecular genetics diagnostic company specializing in the early
detection of cancer and Dante Labs, a global leader in genomics and
precision medicine, announced today a partnership for the
commercialization of ColoAlert 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).
Dante Labs is a global leader in genome sequencing with a
product development and commercial franchise focused on providing
personalized preventive healthcare solutions by leveraging its
robust databases and proprietary software platform to offer
next-generation diagnostic tools direct to consumers and healthcare
professionals. Inherent to Dante Lab’s business model is managing
state-of-the-art genomic sequencing laboratories in multiple
international regions, and operating a robust e-commerce
platform.
“As a young company with the goal of bringing to market
important diagnostic tools to help treat and prevent cancer
indications, it’s an absolute pleasure to partner with an industry
leader such as Dante Labs,” commented Guido Baechler, Chief
Executive Officer of Mainz Biomed. “Our differentiated commercial
plan of partnering with third-party laboratories for test kit
processing versus the traditional methodology of operating a single
facility requires alliances with like-minded companies such as
Dante Labs, who share our passion for forward-thinking diagnostic
test development and marketing strategies.”
The partnership will first launch ColoAlert in Italy and UAE
using Dante’s various established commercial channels. Samples will
initially be processed at Mainz’s in-house facility and then Dante
will purchase Mainz’s CE-IVD polymerase chain reaction (PCR) assay
kits and transition all test processing to Dante’s wholly-owned
automated genomic sequencing laboratories in Italy (Europe) and
Dubai (UAE) to offer localized service and support.
“We are excited by the opportunity to align with Mainz and
represent ColoAlert in these initial markets,” commented Andrea
Riposati, Chief Executive Officer of Dante Labs. “Both the product
and the Company mirror our mission to develop and market top-tier
preventive health solutions and use new channels to make innovative
tests available to more patients around the world. With the launch
of our enhanced ecommerce platforms for advanced diagnostics,
ColoAlert is an amazing product to deliver more personalized
medicine.”
ColoAlert is currently marketed across Europe, and the
partnership with Dante Labs marks the test’s initial launch in the
Middle East. Mainz will continue to develop commercial and R&D
partnerships with companies that lead the field of health screening
with a particular focus on stool diagnostics.
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 LabsDante Labs 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.
Contact:
Laura D’AngeloVP of Investor
Relationsir@dantelabs.com+39 0862 191 0671www.dantelabs.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 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.
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