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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 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.
Mainz Biomed (NASDAQ:MYNZ) has made significant strides in developing PancAlert, a novel screening test for pancreatic cancer, funded by a grant from the German government. The initiative, which began in 2020, aims to provide non-invasive early detection, crucial for improving the low survival rates associated with pancreatic cancer. Recent achievements include meeting specificity targets and developing prototype tests. The company will focus on evaluating various collection methodologies over the next year. CEO Guido Baechler emphasized the project's importance for enhancing diagnostic solutions in cancer detection.
Mainz Biomed has appointed Darin Leigh as Chief Commercial Officer to enhance the international commercialization of ColoAlert and expand its cancer detection product line. With over 25 years of experience in the IVD field and a history of significant revenue generation at Abbott and Luminex, Leigh aims to leverage his expertise to position ColoAlert as a leading solution for colorectal cancer screening. The company anticipates growth in its market presence, particularly with an estimated US market opportunity of approximately $3.7 billion annually.
Mainz Biomed (NASDAQ:MYNZ) reported operational results for Q1 2022, emphasizing progress in commercial activities for its ColoAlert colorectal cancer test. Key highlights include international clinical study initiation (ColoFuture), acquisition of mRNA biomarkers to enhance ColoAlert, and positive FDA feedback for its pivotal trial. The company also commenced its U.S. medical reimbursement process and executed a $25.8 million public offering. CEO Guido Baechler expressed optimism about growth and strategic advancement in the oncology diagnostics market.
Mainz Biomed (NASDAQ:MYNZ) received positive feedback from the FDA on the trial design for its colorectal cancer detection test, ColoAlert. As preparations for a pivotal clinical trial commence, the company initiated its reimbursement process with CMS. This trial aims to evaluate the effectiveness of ColoAlert, which detects CRC through a non-invasive test utilizing DNA analysis. The study, involving over 600 patients, is set to complete enrollment in late 2022, with results expected in early 2023. The U.S. market opportunity for CRC screening is estimated at $3.7 billion annually.
Mainz Biomed N.V. (NASDAQ:MYNZ), a molecular genetics diagnostic company, announced CEO Guido Baechler will ring the closing bell at Nasdaq on March 21, 2022, celebrating its successful listing. Baechler expressed gratitude to shareholders and highlighted significant strides in the company's commercial and operational development. Mainz Biomed focuses on early cancer detection, with its flagship product ColoAlert for colorectal cancer. The company aims for U.S. regulatory approval for ColoAlert in 2022 and has other products in the pipeline, including PancAlert.
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