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Issuer: Mainz BioMed N.V. / Key word(s): Regulatory Admission
Mainz Biomed Announces Submission for FDA Breakthrough Device Designation for its Next Generation CRC Screening Test
2024-07-09 / 09:01 CET/CEST
The issuer is solely responsible for the content of this announcement.
Mainz Biomed Announces Submission for FDA Breakthrough Device Designation for its Next Generation CRC Screening Test
On the basis of its positive clinical studies Mainz Biomed has now defined the final configuration including its novel
mRNA biomarkers of the Next Generation Test to be used in pivotal registration study ReconAAsense
A recent clinical analysis of this new configuration demonstrates sensitivity for colorectal cancer of 97% and 88% for
advanced adenomas, with specificity of 93%
BERKELEY, US - MAINZ, Germany - July 9, 2024 - Mainz Biomed N.V. (NASDAQ: MYNZ), a molecular genetics diagnostic
company specializing in the early detection of cancer, announced that it has submitted its application to the U.S. Food
and Drug Administration (FDA) requesting Breakthrough Device Designation for its non-invasive Next Generation
colorectal cancer (CRC) product including the Company's novel portfolio of mRNA biomarkers. Subject to the FDA's
review, a Breakthrough Device Designation could significantly accelerate approval.
The regulatory submission follows consistently excellent read-outs of its clinical studies ColoFuture and eAArly
Detect, as well as data from a pooled study including both the European and the US arm that were presented at ASCO
2024. On the basis of these studies Mainz Biomed has now defined the final configuration of its Next Generation Test
integrating the Fecal Immunochemical Test (FIT) with proprietary mRNA biomarkers, complemented by an advanced AI and
machine learning algorithm that the Company plans to use in its Next Generation product, and the FDA premarket approval
study.
The configuration of the Next Generation Test was tested in a clinical setting. The analysis involved 295 clinical
subjects from 21 specialized gastroenterology centers across the United States and highlighted the remarkable efficacy
of Mainz Biomed's multimodal screening test. This combination enables precise differentiation among colorectal cancer
(CRC), advanced adenomas (AA), non-advanced adenomas, and samples with no pathological findings.
Key Findings
. Sensitivity for Colorectal Cancer: 97% (95% confidence interval: 83.3-99.9)
. Sensitivity for Advanced Precancerous Lesions: 88% (95% confidence interval: 77.2-94.5)
. Specificity: 93% (95% confidence interval: 88.4-98.3)
Guido Baechler, Chief Executive Officer at Mainz Biomed, commented, "On the back of our extremely positive clinical
results in all our recent studies, finalizing the test which will be used in the pivotal ReconAAsense study and
approval process has been an elementary milestone for our Company. Our Next Generation Test has shown a significant
improvement in sensitivity for advanced adenomas and high-grade dysplasias, combined with high sensitivity and
specificity for CRC. Moreover, we believe that our unique decentralized model of working with third party laboratory
partners provides better access to underserved communities and our simple collection process will increase the
adherence to testing. These benefits support our mission to transform colorectal cancer screening practices and reduce
global cancer mortality rates."
The FDA's Breakthrough Devices Designation is a program for certain medical devices and device-led combination products
that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or
conditions. It is intended to allow patients and health care providers timely access to medical devices by speeding up
development, assessment, and review for premarket approval, 510(k) clearance, and De Novo marketing authorizations.
Breakthrough Devices must meet the FDA's rigorous standards for device safety and effectiveness in order to be
authorized for marketing.
Please visit Mainz Biomed's official website for investors at mainzbiomed.com/investors/ or subscribe to our news
alert to keep up to date on our pivotal FDA PMA clinical trial ReconAAsense and further corporate news.
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About Colorectal Cancer
Colorectal 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 USD4.0B+ 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 AG
Anne Hennecke/Caroline Bergmann
+49 211 529252 20
mainzbiomed@mc-services.eu
For investor inquiries, please contact info@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 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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Language:     English 
Company:      Mainz BioMed N.V. 

Robert-Koch-Strasse 50
55129 Mainz
Germany

Internet:     mainzbiomed.com 
EQS News ID:  1940797 

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July 09, 2024 03:01 ET (07:01 GMT)