$Mainz Biomed (MYNZ.US)$ Mainz Biomed’s **next-generation mu...
$Mainz Biomed (MYNZ.US)$ Mainz Biomed’s **next-generation multimodal screening test** has been under development and recently made significant progress. The test has shown strong performance in various clinical trials, including **ColoFuture** and **eAArly Detect** studies. It integrates the **Fecal Immunochemical Test (FIT)** with proprietary **mRNA biomarkers** and advanced **AI/machine learning** algorithms, offering a more comprehensive approach to colorectal cancer screening [oai_citation:10,Mainz Biomed Announces Submission for FDA Breakthrough Device Designation for its Next Generation CRC Screening Test - Mainz Biomed](https://mainzbiomed.com/mainz-biomed-announces-submission-for-fda-breakthrough-device-designation-for-its-next-generation-crc-screening-test/) [oai_citation:9,Mainz Biomed Announces Submission for FDA Breakthrough](https://www.globenewswire.com/news-release/2024/07/09/2910060/0/en/Mainz-Biomed-Announces-Submission-for-FDA-Breakthrough-Device-Designation-for-its-Next-Generation-CRC-Screening-Test.html).
The efforts Mainz Biomed has made to ensure the success of this multimodal test include:
1. **Clinical Trials and Research**: Mainz Biomed conducted clinical studies such as **ColoFuture** and **eAArly Detect**, which pooled data from the U.S. and Europe. These trials demonstrated the test's high sensitivity and specificity, especially in detecting advanced adenomas and colorectal cancer [oai_citation:8,Mainz Biomed Announces Submission for FDA Breakthrough](https://www.globenewswire.com/news-release/2024/07/09/2910060/0/en/Mainz-Biomed-Announces-Submission-for-FDA-Breakthrough-Device-Designation-for-its-Next-Generation-CRC-Screening-Test.html) [oai_citation:7,Next-Generation ColoAlert Screening Test Shows High Sensitivity, Specificity for CRC and Adenoma Detection](https://www.onclive.com/view/next-generation-coloalert-screening-test-shows-high-sensitivity-specificity-for-crc-and-adenoma-detection).
2. **Regulatory Approvals and Submissions**: The company has focused on securing regulatory approvals by submitting the test for **FDA Breakthrough Device Designation** and preparing for a pivotal FDA clinical study called **ReconAAsense**. This trial is expected to involve 15,000 patients and is a critical step toward U.S. regulatory approval [oai_citation:6,Mainz Biomed Announces Submission for FDA Breakthrough](https://www.globenewswire.com/news-release/2024/07/09/2910060/0/en/Mainz-Biomed-Announces-Submission-for-FDA-Breakthrough-Device-Designation-for-its-Next-Generation-CRC-Screening-Test.html) [oai_citation:5,Mainz Biomed Announces Live Launch of ColoAlert® with testDNA Laboratory in Poland - Mainz Biomed](https://mainzbiomed.com/mainz-biomed-announces-live-launch-of-coloalert-with-testdna-laboratory-in-poland/).
3. **Talent Acquisition and Leadership Expansion**: Mainz Biomed has been expanding its leadership and talent base to support the development and commercialization of the test. For example, they appointed **Karen Richards** as Vice President of Regulatory Affairs to lead the FDA approval process [oai_citation:4,Mainz Biomed Launches Corporate Health Program in Germany for ColoAlert - Mainz Biomed](https://mainzbiomed.com/mainz-biomed-launches-corporate-health-program-in-germany-for-coloalert/).
4. **Partnerships and Lab Networks**: The company has also expanded its partnerships with **regional and national laboratories** across Europe and beyond. For example, it launched ColoAlert in collaboration with **GANZIMMUN Diagnostics** in Germany and **testDNA Laboratory** in Poland, aiming to increase distribution and market penetration [oai_citation:3,Mainz Biomed Expands ColoAlert Commercialization with GANZIMMUN Diagnostics in Europe - Mainz Biomed](https://mainzbiomed.com/mainz-biomed-expands-coloalert-commercialization-with-ganzimmun-diagnostics-in-europe/) [oai_citation:2,Mainz Biomed Announces Live Launch of ColoAlert® with testDNA Laboratory in Poland - Mainz Biomed](https://mainzbiomed.com/mainz-biomed-announces-live-launch-of-coloalert-with-testdna-laboratory-in-poland/).
5. **Product Enhancements**: Mainz Biomed has improved the usability of the test by refining the **collection process** and integrating new features such as a proprietary buffer and advanced testing kits. These enhancements streamline the process, reduce retesting rates, and ensure faster results for patients [oai_citation:1,Mainz Biomed Launches Enhanced ColoAlert to Optimize Screening Efficiency and User Convenience - OncoDaily](https://oncodaily.com/blog/111842).
These combined efforts aim to position Mainz Biomed’s multimodal screening test as a leading solution for early colorectal cancer detection.
The efforts Mainz Biomed has made to ensure the success of this multimodal test include:
1. **Clinical Trials and Research**: Mainz Biomed conducted clinical studies such as **ColoFuture** and **eAArly Detect**, which pooled data from the U.S. and Europe. These trials demonstrated the test's high sensitivity and specificity, especially in detecting advanced adenomas and colorectal cancer [oai_citation:8,Mainz Biomed Announces Submission for FDA Breakthrough](https://www.globenewswire.com/news-release/2024/07/09/2910060/0/en/Mainz-Biomed-Announces-Submission-for-FDA-Breakthrough-Device-Designation-for-its-Next-Generation-CRC-Screening-Test.html) [oai_citation:7,Next-Generation ColoAlert Screening Test Shows High Sensitivity, Specificity for CRC and Adenoma Detection](https://www.onclive.com/view/next-generation-coloalert-screening-test-shows-high-sensitivity-specificity-for-crc-and-adenoma-detection).
2. **Regulatory Approvals and Submissions**: The company has focused on securing regulatory approvals by submitting the test for **FDA Breakthrough Device Designation** and preparing for a pivotal FDA clinical study called **ReconAAsense**. This trial is expected to involve 15,000 patients and is a critical step toward U.S. regulatory approval [oai_citation:6,Mainz Biomed Announces Submission for FDA Breakthrough](https://www.globenewswire.com/news-release/2024/07/09/2910060/0/en/Mainz-Biomed-Announces-Submission-for-FDA-Breakthrough-Device-Designation-for-its-Next-Generation-CRC-Screening-Test.html) [oai_citation:5,Mainz Biomed Announces Live Launch of ColoAlert® with testDNA Laboratory in Poland - Mainz Biomed](https://mainzbiomed.com/mainz-biomed-announces-live-launch-of-coloalert-with-testdna-laboratory-in-poland/).
3. **Talent Acquisition and Leadership Expansion**: Mainz Biomed has been expanding its leadership and talent base to support the development and commercialization of the test. For example, they appointed **Karen Richards** as Vice President of Regulatory Affairs to lead the FDA approval process [oai_citation:4,Mainz Biomed Launches Corporate Health Program in Germany for ColoAlert - Mainz Biomed](https://mainzbiomed.com/mainz-biomed-launches-corporate-health-program-in-germany-for-coloalert/).
4. **Partnerships and Lab Networks**: The company has also expanded its partnerships with **regional and national laboratories** across Europe and beyond. For example, it launched ColoAlert in collaboration with **GANZIMMUN Diagnostics** in Germany and **testDNA Laboratory** in Poland, aiming to increase distribution and market penetration [oai_citation:3,Mainz Biomed Expands ColoAlert Commercialization with GANZIMMUN Diagnostics in Europe - Mainz Biomed](https://mainzbiomed.com/mainz-biomed-expands-coloalert-commercialization-with-ganzimmun-diagnostics-in-europe/) [oai_citation:2,Mainz Biomed Announces Live Launch of ColoAlert® with testDNA Laboratory in Poland - Mainz Biomed](https://mainzbiomed.com/mainz-biomed-announces-live-launch-of-coloalert-with-testdna-laboratory-in-poland/).
5. **Product Enhancements**: Mainz Biomed has improved the usability of the test by refining the **collection process** and integrating new features such as a proprietary buffer and advanced testing kits. These enhancements streamline the process, reduce retesting rates, and ensure faster results for patients [oai_citation:1,Mainz Biomed Launches Enhanced ColoAlert to Optimize Screening Efficiency and User Convenience - OncoDaily](https://oncodaily.com/blog/111842).
These combined efforts aim to position Mainz Biomed’s multimodal screening test as a leading solution for early colorectal cancer detection.
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