Key Findings: 92.3% Sensitivity for Colorectal Cancer, 82.3% for Advanced Precancerous Lesions

Poster presentation showing new data on 690 subjects including previously unexamined and unreported samples from the pooled ColoFuture and eAArly DETECT studies utilizing the mRNA biomarkers, FIT test, and a proprietary AI Algorithm

BERKELEY, Calif. and MAINZ, Germany, May 28, 2024 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQ: MYNZ), a molecular genetics diagnostic company specializing in the early detection of cancer, is excited to announce its participation in the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting. This prestigious conference will be held from May 31 to June 4, 2024, in Chicago, Illinois, and online, serving as a leading forum for the latest developments in oncology.

The combined analysis from the ColoFuture and eAArly DETECT studies represents the largest dataset to date, with 690 subjects including previously unexamined and unreported subjects enrolled across 30 clinical sites. These studies were designed to assess the performance of a novel stool-based approach that combines mRNA signatures and the Fecal Immunochemical Test (FIT) with an AI-generated algorithm to improve diagnostic performance for detecting colorectal cancer and advanced precancerous lesions.

Presentation Details
Title: “A Novel, Non-Invasive, Multimodal Screening Test for Early Detection of Precancerous Lesions and Colorectal Cancer Using an Artificial Intelligence-Based Algorithm.”
Presenter: Dr. D. Kim Turgeon
Session: Saturday, June 1, 2024, from 13:30 to 16:30 CDT
Abstract #: 3627
Poster Bd#: #290
Citation: J Clin Oncol 42, 2024 (suppl 16; abstr 3627)

This multimodal screening test shows a significant improvement over existing non-invasive methods, particularly in detecting advanced precancerous lesions (APLs) such as advanced adenomas, which are critical for early intervention. By leveraging this approach, Mainz Biomed aims to revolutionize colorectal cancer screening practices and contribute to a reduction in cancer mortality rates worldwide.

Please visit Mainz Biomed’s official website for investors at mainzbiomed.com/investors/ for more information.

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About eAArly DETECT and ColoFuture
eAArly DETECT and ColoFuture studies were designed to integrate novel mRNA biomarkers into Mainz Biomed’s pivotal FDA PMA clinical trial ReconAAsense. The studies included 690 evaluable subjects across 21 sites in the U.S. and 9 sites in Europe. The two cohorts included patients (US cohort aged 45 and older and European cohort aged 40 and older) that provided a stool sample before undergoing a colonoscopy to either screen for CRC (average risk), to follow up on a positive non-invasive test, imaging or symptoms, or if a subject was already identified as having colorectal cancer but before any treatment had been administered. Following colonoscopy and any applicable histopathology, subjects were classified into groups: CRC, advanced adenoma, non-advanced adenoma, no findings, or non-colorectal cancer. Each subject outcome was compared to the results from the next generation test incorporating the novel mRNA biomarkers and FIT.

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 $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.   

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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.