New study data confirmed previous ColoFuture and eAArly DETECT study performance with sensitivity for CRC of 92% and 82% for advanced adenomas, including 95.8% detection of high-grade dysplasia
Results from pooled study represents the third consecutive confirmation of the consistently good performance of Mainz Biomed’s mRNA biomarkers to detect CRC and precancerous lesions
BERKELEY, Calif. and MAINZ, Germany, June 03, 2024 (GLOBE NEWSWIRE) — Mainz Biomed N.V. (NASDAQ: MYNZ), a molecular genetics diagnostic company specializing in the early detection of cancer, presented pivotal data from its largest cohort to date during a poster presentation at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting in Chicago, Illinois, and online. This data combines results from the ColoFuture and eAArly DETECT studies including additional patients collected since the first reported study results, demonstrating the significance of its innovative screening approach.
The combined analysis involves 690 clinical subjects from 30 specialized gastroenterology centers across Europe and the United States, including previously unexamined and unreported samples, highlighting the remarkable efficacy of Mainz Biomed’s multimodal screening test. This test integrates the Fecal Immunochemical Test (FIT) with proprietary mRNA biomarkers, complemented by an advanced AI and machine learning algorithm. This combination enables precise differentiation among colorectal cancer (CRC), advanced adenomas (AA), non-advanced adenomas, and samples with no pathological findings.
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
Abstract #: 3627
Poster Bd #: 290
Citation: J Clin Oncol 42, 2024 (suppl 16; abstr 3627)
Key Findings
- Sensitivity for Colorectal Cancer: 92.3% (95% confidence interval: 84.0-97.1)
- Specificity: 90.1% (95% confidence interval: 87.1-92.7)
- Sensitivity for Advanced Precancerous Lesions: 82.2% (95% confidence interval: 75.0-88.0)
- High-Grade Dysplasia Detection Rate: 95.8%
This study highlighted the significant advantage of the multimodal screening test over existing methods, particularly in detecting advanced precancerous lesions. For example, the sensitivity for detecting high-grade dysplasia, which have an increased risk of turning into cancer, with the multimodal approach was 95.8%, significantly higher than other non-invasive tests currently available.
“These results offer the unique promise of a self-administered screening tool with highly effective detection of adenomas (AA), a type of pre-cancerous polyp often attributed to this deadly disease,” commented Dr. Kim Turgeon, M.D., Professor of Gastroenterology and Internal Medicine at University of Michigan Health. “Patients with advanced adenomas have an increased risk of developing colorectal cancer. The significant improvement in AA sensitivity compared to other non-invasive tests currently available, allows for the screening paradigm to shift from cancer detection to prevention. I believe that these results are very promising for the GI community.”
Dr. Moritz Eidens, Chief Scientific Officer at Mainz Biomed, commented, “Combining data from two different studies to achieve these outstanding results is highly unusual and demonstrates the robustness of our multimodal screening test. It is also the third consecutive read-out of scientific data that confirms the ability of our innovative test: the significant improvement in sensitivity for advanced adenomas, combined with high sensitivity and specificity for CRC, supports our mission to transform colorectal cancer screening practices and reduce global cancer mortality rates.”
For more detailed results, visit https://mainzbiomed.com/wp-content/uploads/2024/05/ASCO_MBM_poster.pdf to access the poster with the detailed results.
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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.
