The eAArly DETECT results reported a sensitivity for colorectal cancer of 97% with a specificity of 97% and a sensitivity for advanced adenoma of 82%
BERKELEY, Calif. and MAINZ, Germany, May 07, 2024 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQ:MYNZ), a molecular genetics diagnostic company specializing in the early detection of cancer, will present an analysis from its eAArly DETECT study at Digestive Disease Week (DDW) 2024 in Washington D.C. from May 18th to May 21st. DDW is recognized as a premier forum for the latest advancements in gastroenterology, hepatology, endoscopy, and gastrointestinal surgery.
eAArly DETECT is a US multi-site study performed at 21 specialized gastroenterology sites that enrolled 254 clinical patients. The results show compelling performance of its multimodal screening test combining Fecal Immunochemical Test (FIT), DNA and mRNA biomarkers with a unique artificial intelligence (AI) / machine learning algorithm to differentiate between colorectal cancer (CRC), advanced adenomas (AA), non-advanced adenomas and patient samples with no findings.
The presentation will delve into the test’s ability to accurately analyze a combination of biomarkers, improving early detection rates for both colorectal cancer and significant precancerous conditions. By leveraging this dual approach, Mainz Biomed aims to accelerate the shift from cancer detection to prevention by advancing current colorectal cancer screening practices, reflecting its commitment to reducing cancer mortality rates worldwide.
Presentation Details
Session Title: Cancer, Early Detection, Biomarkers for Diagnosis, Treatment and Prognosis of GI Cancers
Session Sponsor: AGA
Title: "NOVEL STOOL-BASED NON-INVASIVE EARLY DETECTION OF COLORECTAL CANCER AND PRECANCEROUS LESIONS BY CLASSIC FIT COMBINED WITH NUCLEIC ACID-BASED BIOMARKER SIGNATURES."
Presenter: Kammers, L
Session: Sunday, May 19, 2024, from 12:30 PM to 1:30 PM EDT
Poster #: Su1117
Key findings: First analysis of the eAArly DETECT clinical study reported a sensitivity for colorectal cancer of 97% with a specificity of 97% and a sensitivity for advanced adenoma of 82%. Resulting performance data confirms that this multimodal screening strategy reflects a substantial and meaningful improvement for CRC and especially AA detection, where improved sensitivity is urgently needed to decrease CRC incidence and mortality.
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About eAArly DETECT
The eAArly DETECT was performed to identify novel mRNA biomarker for potential integration into the Mainz Biomed’s pivotal FDA PMA clinical trial ReconAAsense. The study enrolled 254 evaluable subjects across 21 sites in the U.S. with a similar design to that of ColoFuture, its European counterpart. Patients aged 45 years and older were invited to participate when referred for 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. Those who agreed to provide a stool sample in advance of the colonoscopy (or treatment in the case of subjects with already identified colorectal cancer) were eligible for participation. Subjects were classified into groups following central pathology review: CRC, advanced adenoma, non-advanced adenoma, no findings, or non-colorectal cancer. Each subject outcome was compared to the results from the ColoAlert® test incorporating the novel biomarkers.
About ColoAlert®
ColoAlert®, Mainz Biomed’s flagship product, delivers high sensitivity and specificity in a user-friendly, at-home colorectal cancer (CRC) screening kit. This non-invasive test can be indicative of tumors as determined by analyzing tumor DNA, offering better early detection than fecal occult blood tests (FOBT). Based on PCR-technology, ColoAlert® detects more cases of colorectal cancer than other stool tests and allows for an earlier diagnosis (Dollinger et al., 2018, Franck et al., 2024). The product is commercially available in select EU countries through a network of leading independent laboratories, corporate health programs and via direct sales. To receive marketing approval in the US, ColoAlert® will be evaluated in the FDA-registration trial ‘ReconAAsense.’ Once approved in the US, 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.
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.
