Mainz Biomed Awarded Poster of Distinction at Digestive Disease Week, Positioning the Company for its Planned FDA Trial

Rhea-AI Summary

Mainz Biomed unveiled groundbreaking eAArly DETECT study results at Digestive Disease Week (DDW) 2024, achieving a Poster of Distinction award. The study demonstrated 97% sensitivity for colorectal cancer (CRC) and 82% for advanced precancerous lesions, with 100% detection in high-grade dysplasia patients. Conducted across multiple US sites with 254 clinical subjects, the study utilized a multimodal screening test combining Fecal Immunochemical Test (FIT), proprietary mRNA biomarkers, AI, and machine learning. These findings highlight a significant improvement in CRC and advanced adenoma (AA) detection, aligning with previous European ColoFuture study results. Mainz Biomed aims to shift from cancer detection to prevention, potentially reducing CRC mortality rates worldwide.

Positive

• Mainz Biomed awarded Poster of Distinction at DDW 2024 for eAArly DETECT study.
• eAArly DETECT study shows 97% sensitivity and specificity for colorectal cancer.
• 82% sensitivity for advanced precancerous lesions achieved.
• 100% detection rate for high-grade dysplasia in advanced precancerous lesion patients.
• Study conducted across multiple US sites with participation from 21 specialized gastroenterology centers.
• Multimodal screening test integrates FIT, proprietary mRNA biomarkers, AI, and machine learning.
• Results reflect meaningful improvement in CRC and AA detection, aligned with European ColoFuture study.
• Potential shift from cancer detection to prevention, aiming to reduce CRC mortality rates.

Negative

• One colorectal cancer patient was not detected at stage I of the disease.
• Study size was to 254 evaluable clinical subjects, which may impact the generalizability of results.

Mainz Biomed Presented Industry Leading Results: 97% Sensitivity for Colorectal Cancer, 82% for Advanced Precancerous Lesions

The eAArly DETECT results demonstrated that within the advanced precancerous lesion patients, 100% of those patients with high grade dysplasia were detected

The Company’s mission is to transform current colorectal cancer screening practices, and ultimately to reduce cancer mortality rates worldwide by shifting from cancer detection to cancer prevention

BERKELEY, Calif. and MAINZ, Germany, May 20, 2024 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQ: MYNZ), a molecular genetics diagnostic company specializing in the early detection of cancer, unveiled key findings from its groundbreaking eAArly DETECT study during a poster presentation at the renowned Digestive Disease Week (DDW) 2024 in Washington D.C. The Company was awarded as a Poster of Distinction by the Digestive Disease Week judges.

The eAArly DETECT study, conducted across multiple sites in the United States with participation from 21 specialized gastroenterology centers, enrolled 254 evaluable clinical subjects. The study results underscore the remarkable efficacy of Mainz Biomed's innovative multimodal screening test. This test integrates the Fecal Immunochemical Test (FIT), along with proprietary mRNA biomarkers, complemented by a sophisticated artificial intelligence (AI) and machine learning algorithm. Together, these components enable precise differentiation among colorectal cancer (CRC), advanced adenomas (AA), non-advanced adenomas, and samples with no pathological findings.

The poster titled ‘Novel Stool-based non-invasive early detection of colorectal cancer and precancerous lesions by classic FIT combined with nucleic acid-based biomarker signatures’ was presented by Dr. Lena Krammes, Senior Scientist at Mainz Biomed. Key findings of the eAArly DETECT clinical study include a sensitivity for colorectal cancer of 97% with a specificity of 97% and a sensitivity for advanced adenoma of 82%. Additionally, the data demonstrated that within the advanced precancerous lesion patients, 100% of those patients with high grade dysplasia (advanced adenomas with a high likelihood of turning into cancer) were detected. Only one of the colorectal cancer patients was not detected at stage I of the disease. Resulting performance data confirms the outcome previously obtained from the separate European ColoFuture study and 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. Visit https://mainzbiomed.com/wp-content/uploads/2024/05/Poster_MBM_DDW_2024_Final.pdf to access the poster with the more detailed results.

“The ability to detect advanced precancerous lesions and in particular advanced adenomas as part of a colorectal screening test is critical to drive a paradigm shift in current frontline screening options,” said Dr Moritz Eidens, Chief Scientific Officer at Mainz Biomed. “We know that 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 combined with the excellent sensitivity and specificity for CRC, allows us to accelerate the shift from cancer detection to prevention. Our mission is to transform current colorectal cancer screening practices, and ultimately to reduce 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
eAArly DETECT was performed to select novel mRNA biomarkers for potential integration into 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 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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Anne Hennecke/Caroline Bergmann
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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.

FAQ

What were the sensitivity and specificity results of the Mainz Biomed eAArly DETECT study?

The eAArly DETECT study showed 97% sensitivity and specificity for colorectal cancer and 82% sensitivity for advanced precancerous lesions.

Where was the Mainz Biomed eAArly DETECT study presented?

The study was presented at Digestive Disease Week (DDW) 2024 in Washington D.C.

What award did Mainz Biomed receive for the eAArly DETECT study?

Mainz Biomed was awarded the Poster of Distinction at DDW 2024.

How many patients participated in the Mainz Biomed eAArly DETECT study?

The study enrolled 254 evaluable clinical subjects across multiple sites in the United States.

What technologies were used in the Mainz Biomed eAArly DETECT screening test?

The screening test integrated Fecal Immunochemical Test (FIT), proprietary mRNA biomarkers, AI, and machine learning.

What is the significance of the Mainz Biomed eAArly DETECT study results?

The results highlight a significant improvement in detecting colorectal cancer and advanced adenomas, potentially shifting from cancer detection to prevention.

Did the Mainz Biomed eAArly DETECT study align with any previous studies?

Yes, the results confirm the outcome previously obtained from the European ColoFuture study.