Mainz Biomed launches eAArly DETECT 2 study to validate colorectal cancer test in average risk patients, targeting 2025 results.
Quiver AI Summary
Mainz Biomed NV has launched the eAArly DETECT 2 feasibility study, aimed at validating previous results on advanced adenomas using a large population of approximately 2,000 average risk patients. This multi-center study incorporates the company's proprietary mRNA biomarkers, an AI-developed algorithm, and a FIT test. Enrollment is expected to be completed in the second half of 2025, with topline results targeted to be reported in the fourth quarter of 2025. Successful results may lead to the initiation of the U.S. pivotal study, ReconAAsense, in 2026. The study seeks to enhance the detection of advanced adenomas and early-stage colorectal cancer, aligning with Mainz Biomed's mission to improve colorectal cancer screening and reduce cancer mortality rates.
Potential Positives
- Launch of eAArly DETECT 2 feasibility study to validate advanced adenomas detection could significantly enhance colorectal cancer screening efficacy.
- Study aims to enroll approximately 2,000 average-risk patients, which may provide robust data to support the next generation of cancer screening tests.
- Successful outcomes from this study could accelerate the initiation of Mainz Biomed's pivotal U.S. study in 2026, potentially leading to regulatory approvals and expanded market presence.
- Innovative use of proprietary mRNA biomarkers combined with an AI algorithm may represent a transformational advancement in self-administered CRC screening, aligning with the company's mission to reduce global cancer mortality rates.
Potential Negatives
- The announcement of the feasibility study suggests that prior studies may not have been definitive enough, raising concerns about the reliability of the company's earlier results.
- The expected reporting timeline of results by the fourth quarter of 2025 indicates a lengthy waiting period, which could impact investor confidence and the company's market position in the meantime.
- The acknowledgment of various risks and uncertainties associated with forward-looking statements may signal potential challenges in meeting development targets, which could affect the company’s projected growth and innovation prospects.
FAQ
What is the eAArly DETECT 2 study?
The eAArly DETECT 2 study is a feasibility study designed to evaluate next-generation colorectal cancer tests using proprietary biomarkers in average risk patients.
When will the eAArly DETECT 2 study be completed?
Enrollment for the eAArly DETECT 2 study is expected to complete in the second half of 2025, with topline results reported in Q4 2025.
How many patients are involved in the eAArly DETECT 2 study?
The study will involve approximately 2,000 average risk patients to validate the test results from previous feasibility studies.
What advancements does the new CRC test offer?
The next-generation CRC test aims to detect advanced adenomas and early-stage CRC with high accuracy, potentially preventing colorectal cancer through early detection.
What are the implications of the study’s results?
Based on the study's outcomes, Mainz Biomed plans to finalize protocols for its pivotal U.S. study, expected to initiate in 2026.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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Full Release
eAArly DETECT 2 feasibility study designed to validate earlier results on advanced adenomas over a large population of average risk patients
Multi-center study expected to complete enrollment in the second half and reporting in the Fourth Quarter of 2025
BERKELEY, Calif. and MAINZ, Germany, Jan. 21, 2025 (GLOBE NEWSWIRE) -- Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today the launch of eAArly DETECT 2, a U.S. feasibility study to evaluate the Company’s next generation colorectal cancer (CRC) test, integrating its proprietary mRNA biomarkers, AI developed algorithm and FIT test, over a population of approximately 2,000 patients, all of average risk, to validate the industry leading results of previous feasibility studies, which included average risk and identified risk patients.
The eAArly DETECT 2 study is expected to complete enrollment in the second half of 2025 and the Company targets reporting topline results by the fourth quarter of 2025. Based on the study’s outcome, Mainz Biomed intends to finalize its protocols for ReconAAsense, the Company’s U.S. pivotal study, which is on track to initiate in 2026. This next-generation CRC test will not only detect cancerous polyps with a high degree of accuracy but can potentially prevent the disease through early detection of precancerous adenomas.
“The launch of eAArly DETECT 2 is an important milestone for the Company as it enables us to accelerate the timeline to evaluate the potential of these biomarkers to be incorporated into our U.S. pivotal study, which is on track to initiate in 2026,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “The potential inclusion of advanced adenomas in Mainz BioMed’s next generation CRC screening test will represent a transformational advancement in self-administered CRC screening. Precise detection of advanced adenomas as well as early-stage CRC supports our mission to transform colorectal cancer screening practices and reduce global cancer mortality rates.”
The five novel gene expression (mRNA) biomarkers, which the Company acquired from the Sherbrooke University in 2022, have demonstrated a unique ability to identify advanced adenomas, i.e. curable precancerous colonic polyps, as well as treatable early-stage CRC. The eAArly DETECT 2 study will further evaluate and confirm the effectiveness of these biomarkers combined with Mainz Biomed’s proprietary AI algorithm to enhance product specifications to extend its capability to include the identification of advanced adenomas while increasing rates of diagnostic sensitivity and specificity for early-stage CRC.
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About Mainz Biomed NV
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. ColoAlert
®
is marketed across Europe and the United Arab Emirates. The Company is currently running 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 based on real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in stool samples. To learn more, visit
mainzbiomed.com
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For media inquiries
MC Services AG
Anne Hennecke/Simone Neeten
+49 211 529252 22
mainzbiomed@mc-services.eu
For investor inquiries, please contact
ir@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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