Mainz Biomed Launches Ecommerce Store for ColoAlert to Assist Patient Access during Covid-19 Pandemic
07 December 2021 - 7:01PM
Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”),
a molecular genetics diagnostic company specializing in the early
detection of cancer, is pleased to announce the launch of
ColoAlert.de, an ecommerce store providing Germans direct access to
its ColoAlert colorectal cancer (CRC) screening test. German
residents unable to obtain timely CRC screening via in-person
physician visits, will be able to order ColoAlert directly to their
home and receive highly accurate results within a maximum of nine
working days.
“In recent years, the largest decreases in CRC mortality have
been in countries with long-standing screening programs, and we are
excited to bring ColoAlert, a unique, easy-to-use diagnostic test
that is highly efficacious to market,” commented Guido Baechler,
Chief Executive Officer of Mainz Biomed. “As we launch ColoAlert
across Europe through partnerships with regional laboratories, we
are mindful that the Coronavirus pandemic has made it difficult to
access CRC testing via in-person physician visits. As such, we are
excited to leverage our in-house lab in Mainz, Germany, to provide
an efficient CRC screening alternative to ensure that anyone in the
country interested in performing a test has access to a top-tier
solution.”
This direct-to-patient program will utilize Mainz Biomed’s own,
high-throughput, clinical lab based in Mainz, and be administered
by in-house physicians. The Company’s clinical team will also be on
hand to provide phone-based support to ensure a high level of
patient care. In line with Mainz Biomed’s business strategy, it is
expected that ColoAlert.de and other Company-owned online points of
sale will eventually distribute orders for diagnostic tests to
partner labs within the network, both within Germany and globally
as further regulatory approvals are secured and member labs
integrated.
Colorectal cancer is the second deadliest cancer in the European
Union (EU), with approximately 170,000 people dying every year, out
of a diagnosed population of 370,000. According to Digestive
Cancers Europe*, if the European Union was able to diagnose more
patients in stage 1 from the current 13% to 50%, 130,000 more lives
could be saved per year and more than 3 billion € in healthcare
budget savings could be generated every year, and possibly the same
amount in social and work-related value.
*https://www.digestivecancers.eu/wp-content/uploads/2020/02/466-Document-DiCEWhitePaper2019.pdf
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 European 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 estimates that in 2021 there will
be 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. In the USA, Mainz Biomed will
begin the clinical study and regulatory process in the first half
of 2022 for U.S. FDA 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
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. 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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