Mainz Biomed Announces Submission for FDA Breakthrough Device Designation for its Next Generation CRC Screening Test

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Mainz Biomed has submitted an application to the FDA for Breakthrough Device Designation for its Next Generation CRC Screening Test, which incorporates novel mRNA biomarkers. The submission follows promising results from the ColoFuture and eAArly Detect studies, showing 97% sensitivity for colorectal cancer and 88% for advanced adenomas, with 93% specificity. The test uses a combination of Fecal Immunochemical Test (FIT) and proprietary mRNA biomarkers, supported by AI and machine learning algorithms. If approved, the FDA designation could accelerate the product's market release, providing more effective cancer detection and potentially improving global CRC screening practices.

  • Mainz Biomed submitted an application for FDA Breakthrough Device Designation for its Next Generation CRC Screening Test.
  • The test demonstrated 97% sensitivity for colorectal cancer and 88% sensitivity for advanced adenomas.
  • The specific configuration includes novel mRNA biomarkers and AI algorithms.
  • The Breakthrough Device Designation could significantly accelerate product approval.
  • None.

Mainz Biomed's submission to the FDA for Breakthrough Device Designation is a key development. The FDA's rigorous standards necessitate robust data and Mainz Biomed’s clinical results—showing 97% sensitivity for colorectal cancer and 93% specificity—are noteworthy. These metrics are considerably high, suggesting a strong competitive advantage. If the designation is granted, it could expedite the approval process, allowing the company to bring its product to market faster, potentially leading to significant revenue growth. However, it’s important to note that there is always the risk of delays or additional regulatory scrutiny, which could impact timelines and costs.

The integration of AI and machine learning in their diagnostic tests is another promising aspect. This could lead to more accurate diagnostics and potentially lower costs in the long run. The decentralized model mentioned by the CEO might also reduce operational expenditures and improve scalability. Investors should closely monitor the FDA’s review process and any subsequent updates from the company regarding the approval timeline.

The application for FDA Breakthrough Device Designation underscores the potential medical significance of Mainz Biomed’s Next Generation Test. The 97% sensitivity for detecting colorectal cancer and the 88% sensitivity for advanced adenomas are impressive figures that could translate into more effective early detection, which is critical in cancer treatment. A high specificity rate of 93% means fewer false positives, reducing unnecessary procedures and anxiety for patients.

However, these results were obtained in a controlled clinical setting with a relatively small sample size (295 subjects). Real-world efficacy can sometimes vary due to different population characteristics and adherence rates. The AI and machine learning components add a modern edge to the diagnostic process, potentially improving its accuracy over time as more data are accumulated. This could be a game-changer in the colorectal cancer screening space, making it vital for investors to watch how these advancements translate into clinical practice and adoption rates.

From a market perspective, Mainz Biomed’s innovative approach in integrating proprietary mRNA biomarkers and AI technologies into their CRC screening test could significantly disrupt the existing market. The colorectal cancer screening market is substantial and efficient, non-invasive tests with high sensitivity and specificity have a strong potential for wide adoption. The decentralized model of working with third-party laboratories can help increase market penetration, especially in underserved communities, potentially expanding their customer base.

The market’s response will heavily depend on FDA’s decision. A Breakthrough Device Designation will not only speed up the process but also convey a strong endorsement from a regulatory standpoint, which can boost investor confidence. However, it’s important to be cautious about competition in this space, as other companies are also developing advanced diagnostic tools. Continuous innovation and strong execution of marketing and distribution strategies will be key to maintaining a competitive edge.

On the basis of its positive clinical studies Mainz Biomed has now defined the final configuration including its novel mRNA biomarkers of the Next Generation Test to be used in pivotal registration study ReconAAsense

A recent clinical analysis of this new configuration demonstrates sensitivity for colorectal cancer of 97% and 88% for advanced adenomas, with specificity of 93%

BERKELEY, Calif. and MAINZ, Germany, July 09, 2024 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQ: MYNZ), a molecular genetics diagnostic company specializing in the early detection of cancer, announced that it has submitted its application to the U.S. Food and Drug Administration (FDA) requesting Breakthrough Device Designation for its non-invasive Next Generation colorectal cancer (CRC) product including the Company’s novel portfolio of mRNA biomarkers. Subject to the FDA’s review, a Breakthrough Device Designation could significantly accelerate approval.

The regulatory submission follows consistently excellent read-outs of its clinical studies ColoFuture and eAArly Detect, as well as data from a pooled study including both the European and the US arm that were presented at ASCO 2024. On the basis of these studies Mainz Biomed has now defined the final configuration of its Next Generation Test integrating the Fecal Immunochemical Test (FIT) with proprietary mRNA biomarkers, complemented by an advanced AI and machine learning algorithm that the Company plans to use in its Next Generation product, and the FDA premarket approval study.

The configuration of the Next Generation Test was tested in a clinical setting. The analysis involved 295 clinical subjects from 21 specialized gastroenterology centers across the United States and highlighted the remarkable efficacy of Mainz Biomed's multimodal screening test. This combination enables precise differentiation among colorectal cancer (CRC), advanced adenomas (AA), non-advanced adenomas, and samples with no pathological findings.  

Key Findings

  • Sensitivity for Colorectal Cancer: 97% (95% confidence interval: 83.3-99.9)
  • Sensitivity for Advanced Precancerous Lesions: 88% (95% confidence interval: 77.2-94.5)
  • Specificity: 93% (95% confidence interval: 88.4-98.3)

Guido Baechler, Chief Executive Officer at Mainz Biomed, commented, “On the back of our extremely positive clinical results in all our recent studies, finalizing the test which will be used in the pivotal ReconAAsense study and approval process has been an elementary milestone for our Company. Our Next Generation Test has shown a significant improvement in sensitivity for advanced adenomas and high-grade dysplasias, combined with high sensitivity and specificity for CRC. Moreover, we believe that our unique decentralized model of working with third party laboratory partners provides better access to underserved communities and our simple collection process will increase the adherence to testing. These benefits support our mission to transform colorectal cancer screening practices and reduce global cancer mortality rates.”

The FDA’s Breakthrough Devices Designation is a program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. It is intended to allow patients and health care providers timely access to medical devices by speeding up development, assessment, and review for premarket approval, 510(k) clearance, and De Novo marketing authorizations. Breakthrough Devices must meet the FDA’s rigorous standards for device safety and effectiveness in order to be authorized for marketing.

Please visit Mainz Biomed’s official website for investors at or subscribe to our news alert to keep up to date on our pivotal FDA PMA clinical trial ReconAAsense and further corporate news.

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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   

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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 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.


What is Mainz Biomed's Next Generation CRC Screening Test?

It is a non-invasive colorectal cancer screening test that integrates Fecal Immunochemical Test (FIT) with novel mRNA biomarkers and advanced AI algorithms.

What sensitivity and specificity does the Next Generation CRC Screening Test exhibit?

The test shows 97% sensitivity for colorectal cancer, 88% sensitivity for advanced adenomas, and 93% specificity.

What is the significance of the FDA Breakthrough Device Designation for Mainz Biomed's test?

The designation can accelerate the approval process, enabling faster market release and more timely access for patients and healthcare providers.

What studies supported Mainz Biomed's application for the FDA Breakthrough Device Designation?

The application was supported by positive results from the ColoFuture and eAArly Detect clinical studies, as well as a pooled study presented at ASCO 2024.

How does Mainz Biomed's test improve colorectal cancer screening?

The test's high sensitivity and specificity, combined with its non-invasive nature and advanced AI support, provide more accurate and accessible screening options for earlier detection and treatment.

Mainz Biomed N.V.


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