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Mainz Biomed N.V. - MYNZ STOCK NEWS

Welcome to our dedicated page for Mainz Biomed N.V. news (Ticker: MYNZ), a resource for investors and traders seeking the latest updates and insights on Mainz Biomed N.V. stock.

Mainz Biomed N.V. (symbol: MYNZ) is a pioneering company in the field of molecular genetic diagnostics, dedicated to providing patient-friendly testing solutions for life-threatening conditions. With a mission to improve early detection rates and thereby save lives through science, Mainz Biomed develops market-ready products that are both accurate and easy to use.

One of their key innovations is ColoAlert®, a non-invasive, at-home screening test for colorectal cancer (CRC). Utilizing real-time Polymerase Chain Reaction (PCR) to detect molecular-genetic biomarkers in stool samples, ColoAlert® offers high sensitivity and specificity. This test is available in select European countries and is poised for FDA approval in the United States through the ongoing 'ReconAAsense' clinical trial.

Mainz Biomed aims to expand its market reach by fostering partnerships with laboratories and healthcare providers. The company is also committed to advancing the early detection of other cancers, including pancreatic cancer, through products like PancAlert, which is currently in early stages of development.

Recently, Mainz Biomed showcased ColoAlert® at the UDH Congress, emphasizing its role in enhancing comprehensive health strategies. The company reported a 69% year-over-year revenue increase for ColoAlert® and maintained a stable financial condition with a $7.1 million cash balance at year-end.

In collaboration with healthcare professionals, Mainz Biomed continues to contribute to scientific research and knowledge exchange. This commitment was highlighted by their latest clinical studies, ColoFuture and eAArly DETECT, which demonstrated extraordinary statistical significance in CRC and advanced adenoma detection.

For more details, visit Mainz Biomed's official website at www.mainzbiomed.com.

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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.

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Mainz Biomed N.V. (NASDAQ: MYNZ), a molecular genetics diagnostic company focusing on early cancer detection, has provided a mid-year corporate update for 2024. The company highlighted its significant accomplishments in the first half of 2024, emphasizing the strong clinical data from various studies.

Mainz Biomed presented pooled study results at ASCO 2024, confirming previous findings with a 92% sensitivity for colorectal cancer (CRC) and 82% for advanced adenomas, including 95.8% for high-grade dysplasia. Additionally, the company received a Poster of Distinction at Digestive Disease Week for its eAArly DETECT study, demonstrating 97% sensitivity for CRC and 82% for advanced precancerous lesions.

Mainz Biomed engaged in strategic partnerships, notably with Trusted Health Advisors for its U.S. go-to-market strategy and TomaLab for launching ColoAlert® in Italy. These collaborations are pivotal for the company's FDA premarket approval plans and market expansion efforts.

The company remains on track for its U.S. FDA pivotal CRC study, set to begin enrollment in the second half of 2024.

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Mainz Biomed presented findings from their largest cohort study at the ASCO 2024 Annual Meeting. The study, involving 690 clinical subjects from 30 specialized gastroenterology centers across Europe and the US, confirmed the high sensitivity and specificity of their multimodal screening test for colorectal cancer (CRC) and advanced adenomas (AA). The test integrates Fecal Immunochemical Test (FIT) with proprietary mRNA biomarkers, supported by AI and machine learning algorithms. The results showed a 92.3% sensitivity for CRC, 90.1% specificity, and 82.2% sensitivity for AA, with a 95.8% detection rate for high-grade dysplasia, demonstrating superior performance over existing non-invasive methods.

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Mainz Biomed held its 2024 Annual General Meeting on May 31, 2024, in Amsterdam. Shareholders representing 10.9% of the company's ordinary shares attended, meeting the quorum requirement. All proposals, including the adoption of the statutory annual accounts, discharge of directors, amendments to the articles of association, and reappointment of directors, were approved with significant majorities. The company also disclosed a non-compliance notice from Nasdaq for failing to meet the minimum bid price requirement, giving Mainz Biomed 180 days to regain compliance. Failure to comply by November 25, 2024, could result in delisting, although an extension may be granted.

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Mainz Biomed will present its largest colorectal cancer screening study to date at the ASCO 2024 Annual Meeting. The study, combining data from ColoFuture and eAArly DETECT studies, includes 690 subjects across 30 clinical sites. The novel screening test, which uses mRNA biomarkers, FIT tests, and an AI algorithm, showed a 92.3% sensitivity for colorectal cancer and 82.3% for advanced precancerous lesions. This innovative, non-invasive approach aims to enhance early detection of colorectal cancer and advanced adenomas, potentially reducing cancer mortality rates globally. The presentation session will be held on June 1, 2024, from 13:30 to 16:30 CDT.

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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.

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Mainz Biomed N.V. will present the results of its eAArly DETECT study at Digestive Disease Week in Washington D.C. The study reported a sensitivity for colorectal cancer of 97% and a specificity of 97%, along with a sensitivity for advanced adenoma of 82%. The results indicate promising performance of a multimodal screening test combining various biomarkers with an AI algorithm to improve early detection rates for colorectal cancer and precancerous conditions.

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Mainz Biomed reports positive topline results from a pooled study evaluating novel mRNA biomarkers and a proprietary AI algorithm for integration into a pivotal FDA PMA clinical trial for next-generation colorectal cancer diagnostic. The groundbreaking results show a sensitivity for colorectal cancer of 92% with specificity of 90% and best-in-class sensitivity for advanced adenoma of 82%. The study included 690 subjects from Mainz Biomed's clinical trials, aiming to optimize sensitivity and specificity in CRC screening. The results represent a critical milestone towards launching the FDA PMA pivotal study ReconAAsense, planned to recruit up to 15,000 patients. Mainz Biomed's innovative next-generation test has the potential to disrupt the at-home CRC diagnostic screening market by providing a robust and accurate test.
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Mainz Biomed N.V. reported a 69% increase in revenue year over year, with a net loss in line with the previous year. The company's cash balance at year-end was $7.1 million. Key highlights include positive clinical study results for colorectal cancer detection, progress towards FDA PMA study for a self-administered CRC screening tool, and expansion of international commercialization of ColoAlert®. Financially, the company saw revenue growth, but also significant operating expenses leading to a net loss.
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Mainz Biomed N.V. (MYNZ) to host HALLO DOC! event focusing on molecular genetics diagnostic solutions for early cancer detection.
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FAQ

What does Mainz Biomed specialize in?

Mainz Biomed specializes in developing molecular genetic diagnostic solutions for early detection of life-threatening conditions, such as colorectal and pancreatic cancers.

What is ColoAlert®?

ColoAlert® is Mainz Biomed's flagship product, a non-invasive, at-home test for colorectal cancer that uses PCR technology to detect molecular-genetic biomarkers in stool samples.

Where is ColoAlert® available?

ColoAlert® is currently available in select European countries and is undergoing FDA approval for the U.S. market.

What recent achievements has Mainz Biomed made?

Mainz Biomed recently presented significant clinical study results at the UDH Congress and reported a 69% year-over-year revenue increase for ColoAlert®.

What is the ReconAAsense trial?

The ReconAAsense trial is Mainz Biomed's FDA-registration study designed to evaluate ColoAlert® for U.S. regulatory approval.

What other products does Mainz Biomed have in development?

Apart from ColoAlert®, Mainz Biomed is developing PancAlert, an early-stage screening test for pancreatic cancer.

How does ColoAlert® differ from other CRC screening tests?

ColoAlert® offers higher accuracy and earlier detection rates compared to traditional fecal occult blood tests (FOBT), thanks to its advanced PCR-based technology.

What is Mainz Biomed’s mission?

Mainz Biomed's mission is to save lives through science by providing accurate, easy-to-use diagnostic solutions for early detection of deadly conditions.

How does Mainz Biomed contribute to the healthcare sector?

Mainz Biomed contributes through scientific research, innovative diagnostic solutions, and partnerships with healthcare professionals to improve early detection and patient care.

Where can I find more information about Mainz Biomed’s investor relations?

For more information on investor relations, visit Mainz Biomed’s official website at www.mainzbiomed.com/investors/.

Mainz Biomed N.V.

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