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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, a molecular genetics diagnostic company, has engaged DCN Dx to conduct a European clinical study for its ColoAlert test, aimed at detecting colorectal cancer. This partnership focuses on integrating recently acquired mRNA biomarkers to enhance ColoAlert's accuracy in detecting pre-cancerous lesions. The study is set to begin in H1 2022, with potential implications for U.S. FDA approval. With the colorectal cancer market projected at $3.7 billion in the U.S., successful results could establish ColoAlert as a leading at-home screening test.
Mainz Biomed N.V. (NASDAQ:MYNZ) announced the appointment of Dr. Michele Pedrocchi to its Strategic Advisory Board. Dr. Pedrocchi, a seasoned healthcare executive with over 25 years at Roche, brings extensive experience in in vitro diagnostics and international market launches. His expertise is expected to enhance the company’s flagship product, ColoAlert, which is designed for early colorectal cancer detection. The company aims to expand its commercial presence across Europe and beyond. Dr. Pedrocchi will also support strategic partnerships related to product development and distribution.
Mainz Biomed N.V. (NASDAQ:MYNZ) announced its participation in the H.C. Wainwright Bioconnect Virtual Conference from January 10-13, 2022. CEO Guido Baechler will present at the event, which can be accessed online. Mainz Biomed specializes in molecular genetics diagnostics, focusing on early cancer detection, particularly with its ColoAlert test for colorectal cancer, which has a high accuracy and is CE-IVD marked. The U.S. market opportunity for colorectal cancer testing is estimated at $3.7 billion annually, with significant growth expected in the 50+ population.
Mainz Biomed (NASDAQ:MYNZ) has secured a Technology Rights Agreement with TTS, gaining access to a portfolio of mRNA biomarkers aimed at enhancing its ColoAlert colorectal cancer screening test. This agreement positions ColoAlert to possibly become the leading at-home screening solution, with previous studies indicating high sensitivity (75% for advanced adenomas and 95% for colorectal cancer). The company plans to initiate a clinical study in Europe to assess these biomarkers, targeting a launch in the first half of 2022. ColoAlert is already CE-IVD marked and aims for U.S. regulatory approval soon.
Mainz Biomed (NASDAQ:MYNZ) announced the appointment of Karen Richards as Vice President of Regulatory Affairs. This strategic hire is expected to aid in navigating U.S. regulatory processes for their colorectal cancer detection product, ColoAlert. With over 30 years in the in vitro diagnostics sector, Richards' extensive experience includes spearheading regulatory approvals globally. ColoAlert, already marketed in Europe, detects early-stage colorectal cancer and has a significant market potential in the U.S., estimated at $3.7 billion annually, given the rising population of those eligible for testing.
Mainz Biomed N.V. (NASDAQ:MYNZ) has partnered with GANZIMMUN Diagnostics to co-brand its colorectal cancer detection test, ColoAlert, in Germany. GD is one of Europe's leading labs, processing around 5,500 orders daily with an expert team of over 370 professionals. GD will purchase customized PCR assay kits from Mainz to enhance colorectal cancer prevention efforts in major cities like Mainz, Wiesbaden, and Frankfurt. This collaboration aims to establish efficient commercial partnerships to improve test accessibility and reliability, positioning ColoAlert as a critical diagnostic tool in early cancer detection.
Mainz Biomed has launched ColoAlert.de, an e-commerce platform allowing German residents to access its colorectal cancer screening test directly. The test offers highly accurate results within nine working days, catering to those facing challenges in obtaining in-person screenings due to the COVID-19 pandemic. The company aims to enhance early detection of colorectal cancer, which affects 370,000 diagnosed patients annually in the EU, reducing mortality rates and healthcare costs in the process.
Mainz Biomed (NASDAQ:MYNZ) announced on Nov 30, 2021, its collaboration with Precision for Medicine to support U.S. regulatory and reimbursement strategies for ColoAlert, a colorectal cancer diagnostic test. This partnership aims to enhance the test's market access and FDA approval process, crucial for its commercial success.
ColoAlert, which boasts high sensitivity and specificity, is already available in Europe. It offers significant potential in the U.S. market, with an estimated opportunity of $3.7 billion annually as the population over 50 increases.
Mainz Biomed has appointed Dr. Soren Thestrup-Nielsen M.D. to its Strategic Advisory Board, enhancing its expertise in cancer diagnostics. With over 25 years in the medical device industry, Dr. Thestrup-Nielsen will focus on product strategy and market development for the company's flagship product, ColoAlert, which is geared for colorectal cancer detection. The company plans to begin clinical studies for U.S. FDA approval in early 2022. This strategic addition aims to bolster Mainz Biomed’s commercial efforts in Europe and the U.S.
Mainz Biomed (NASDAQ:MYNZ) announced its participation in MEDICA 2021, the largest medical trade fair, showcasing its ColoAlert diagnostic test for colorectal cancer from November 15-18 in Düsseldorf, Germany. After a successful IPO, the company aims to ramp up commercial activities for ColoAlert, which detects CRC with high sensitivity and specificity. The test is currently available in select EU countries, with plans for U.S. approval underway. The potential U.S. market for ColoAlert is estimated at $3.7 billion annually, considering the growing population of Americans aged 50 and above.
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