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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.
Mainz Biomed has appointed Dr. Frank Krieg-Schneider as Vice President of Development to enhance its cancer detection portfolio, including the flagship product ColoAlert. Dr. Krieg-Schneider brings over 25 years of experience in diagnostics, having previously held executive roles at QIAGEN and GNA Biosolutions. His role will focus on advancing ColoAlert through the integration of novel mRNA biomarkers and ensuring compliance with US regulatory standards to support FDA submission. The company aims to significantly expand its market presence, particularly in the US, addressing a potential $3.7 billion opportunity.
Mainz Biomed N.V. (NASDAQ:MYNZ) has established a Medical Advisory Board (MAB) with Dr. Timothy Wang as its inaugural member. The MAB aims to support the forthcoming U.S. pivotal trial for ColoAlert, a colorectal cancer detection test, and evaluate its potential for additional oncology applications. Dr. Wang's expertise in gastroenterology and cancer research enhances the team's capabilities. The pivotal trial is set to start in 2023 following positive feedback from the FDA. Mainz is also advancing ColoFuture, a clinical study aimed at integrating novel biomarkers to improve detection sensitivity.
Mainz Biomed N.V. (NASDAQ:MYNZ) will host a webcast today, July 12, 2022, at 4:00 PM ET to discuss its first half 2022 progress and future plans. The forum will cover its flagship product, ColoAlert, a non-invasive colorectal cancer detection test, including updates on its U.S. regulatory approval and ongoing R&D initiatives. The company aims to enhance ColoAlert's profile while developing additional diagnostic solutions. CEO Guido Baechler emphasized the operational advancements since the company's public transition in November 2021.
Mainz Biomed is set to host a webcast on July 12, 2022, at 4:00 PM ET to discuss its first-half 2022 progress and future plans. The session will feature updates on its flagship product, ColoAlert, a non-invasive colorectal cancer detection test. The webcast aims to inform investors about ColoAlert's regulatory pathway and ongoing R&D efforts to enhance its effectiveness. CEO Guido Baechler emphasized the importance of this update following the company’s transition to the public sector in November 2021.
Mainz Biomed (NASDAQ:MYNZ) has initiated the ColoFuture clinical trial to enhance the ColoAlert test for colorectal cancer detection. The trial, involving over 600 patients across Norway and Germany, aims to incorporate novel mRNA biomarkers acquired from Université de Sherbrooke, and results are expected by early 2023. If successful, these developments could position ColoAlert as a leading home screening test. Additionally, Mainz is preparing for a pivotal U.S. trial, which will adapt based on ColoFuture outcomes.
Mainz Biomed has appointed Jane Edwards as VP of Clinical Affairs, bringing over 20 years of expertise in clinical trial strategies. Her role involves managing clinical trials for ColoAlert, the company’s early detection test for colorectal cancer, to support FDA submission. This test has high sensitivity and specificity rates, and its US market potential is estimated at $3.7 billion annually. Mainz Biomed is targeting completion of patient enrollment for the ColoFuture study in 2022, with results expected in 2023, further enhancing its product’s prospects.
Mainz Biomed N.V. (NASDAQ:MYNZ) announced its compliance with the new EU In Vitro Diagnostic Devices Regulation (IVDR), a key milestone for the company. The ColoAlert patient kit is now CE marked following this stringent regulatory framework that mandates higher quality and safety standards for in vitro diagnostic products. CEO Guido Baechler emphasized the importance of compliance for market expansion. The company aims for the ColoAlert test to enhance early colorectal cancer detection, leveraging a significant market opportunity of approximately $3.7 billion in the US alone.
Mainz Biomed (NASDAQ:MYNZ) has partnered with Dante Labs, a leader in genomics, to commercialize its ColoAlert colorectal cancer test in Italy and the UAE. ColoAlert is an at-home detection test with high sensitivity and specificity. Initially, testing will be processed in Mainz’s facility before transitioning to Dante’s labs. This partnership marks ColoAlert's entry into the Middle East, with Mainz aiming to expand its market presence. The company plans to continue developing partnerships for cancer diagnostics, emphasizing early detection's importance in improving survival rates.
Mainz Biomed N.V. (NASDAQ:MYNZ) announced participation in two investor conferences in May 2022. The H.C. Wainwright Global Investment Conference will be held from May 23-26 in Miami, Florida, with a presentation scheduled for May 24 at 7am ET. Meanwhile, the Equity Forum German Spring Conference takes place from May 23-25 in Frankfurt, Germany, featuring a presentation at 8:30am CET on May 24. The company is known for its ColoAlert test for early colorectal cancer detection, which is CE-IVD marked and expanding into the U.S. market.
Mainz Biomed N.V. (NASDAQ:MYNZ) will host key opinion leaders in colorectal cancer diagnostics at Digestive Disease Week (DDW 2022) in San Diego from May 21-24, 2022. CEO Guido Baechler highlights the event's importance for advancing colorectal cancer detection and prevention. The DDW is the largest international meeting for digestive disease professionals and will showcase over 5,000 abstracts. Mainz Biomed's ColoAlert, a non-invasive test for colorectal cancer, aims to improve early detection and is set for U.S. market entry following FDA approval.
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