Mainz Biomed Partners with Precision for Medicine to Support ColoAlert in the United States … | Nation / World
BERKELEY, Calif. And MAINZ, Germany, November 30, 2021 (GLOBE NEWSWIRE) – Mainz Biomed NV (NASDAQ: MYNZ) (âMainz Biomedâ or the âCompanyâ), a molecular genetic diagnostics company specializing in the early detection of cancer , today announced that the company has engaged Precision for Medicine, a leading global clinical research organization, to provide regulatory and reimbursement advisory support in the United States for ColoAlert, the highly effective diagnostic test and easy to use Mainz for colorectal cancer.
“As an emerging commercial stage company with a portfolio of non-invasive and highly effective diagnostics for the detection of cancer indications at an early stage in development, we recognize the need to operate a streamlined business and clinical organization.” , commented Guido Baechler, Chief Executive Officer of Mainz Biomed. âI am extremely happy to partner with Precision for Medicine as they provide leading and comprehensive solutions that can help ensure ColoAlert is well positioned for FDA regulatory approval and Centers for acceptance. Medicare and Medicaid (CMS) for reimbursement, which of course is essential to gain commercial traction.
Precision for Medicine will work with the Mainz management team to develop and implement a United States-focused regulatory and market access strategy for ColoAlert, the company’s unique and vital early detection test for the colorectal cancer (CRC). This will include assistance in writing ColoAlert’s clinical development plan to ensure that the trial design is cost effective, robust and efficient. Inherent in this exercise will be the integration of CMS guidelines, using CRC screening tests currently marketed as benchmarks to provide ColoAlert with an optimal product profile for regulatory approval and market success. Along the way, Precision for Medicine will advise Mainz throughout its interaction with the FDA pre-submission protocol.
ColoAlert detects colorectal cancer (CRC) via a simple-to-administer test with a sensitivity and specificity almost as high as an invasive colonoscopy *. The test uses proprietary methods to analyze cellular DNA for specific tumor markers combined with the fecal immunochemistry (FIT) test and is designed to detect tumor DNA and early-stage CRC cases. The product is CE-IVD marked (complies with EU safety, health and environmental requirements) and is in transition to IVDR compliance. The product is commercially available in selected countries of the European Union. Mainz Biomed currently distributes ColoAlert through a number of clinical subsidiaries. Once approved in the United States, the Company’s business strategy is to establish scalable distribution through a collaborative partnership program with regional and national laboratory service providers across the country.
* Dollinger MM et al. (2018)
About colorectal cancer
Colorectal cancer (CRC) is the second deadliest cancer in the United States and Europe, but also the most preventable with early detection offering survival rates over 90%. Annual testing costs per patient are minimal, especially compared to advanced stage CRC treatments which cost patients an average of $ 38,469 per year. The American Cancer Society estimates that by 2021 there will be approximately 149,500 new cases of colon and rectal cancer in the United States, of which 52,980 will result in death. Recent decisions from the FDA suggest that screening with stool DNA tests such as ColoAlert in the United States should be done once every three years starting at age 45. There are currently 112 million Americans aged 50 and over, a total expected to increase to 157 million within 10 years. Appropriately testing these 50+ US-based populations every three years, as directed, equates to a US market opportunity of approximately $ 3.7 billion per year.
About Mainz Biomed NV
Mainz Biomed develops market-ready molecular genetic diagnostic solutions for life-threatening diseases. The company’s flagship product is ColoAlert, an accurate, non-invasive and easy-to-use early detection diagnostic test for colorectal cancer. ColoAlert is currently marketed across Europe with a clinical study and FDA submission process slated to launch in the first half of 2022 for regulatory approval in the United States. Mainz Biomed’s product candidate portfolio includes PancAlert, an early stage pancreatic cancer screening test based on real-time multiplex polymerase chain reaction (PCR) detection of molecular genetic biomarkers in samples stool, and GenoStick technology, a platform under development to detect pathogens on a molecular genetic basis.
For more information, please visit www.mainzbiomed.com
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About Precision for Medicine
Precision for Medicine is the premier biomarker-focused clinical research services organization supporting life science companies in using essential biomarkers to target patient treatments more accurately and efficiently. Precision applies novel biomarker approaches to clinical research that integrate clinical trial execution with in-depth scientific knowledge, laboratory expertise, and advanced data science. This convergence of testing, laboratory and data science accelerates clinical development and approval. Precision for Medicine is part of the Precision Medicine group with more than 2,500 people at 40 sites in the United States, Canada and Europe. For more information, visit https://www.precisionformedicine.com.
Certain statements made in this press release are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate”, âBelieveâ, âexpectâ, âestimateâ, âplanâ, âoutlookâ and âprojectâ and other similar expressions which predict or indicate future events or trends or which are not statements of historical questions. These forward-looking statements reflect the current analysis of existing information and are subject to various risks and uncertainties. Therefore, caution should be exercised in relying on forward-looking statements. Due to known and unknown risks, actual results may differ materially from the Company’s expectations or projections. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: (i) failure to achieve projected development and related objectives; (ii) changes in applicable laws or regulations; (iii) the effect of the COVID-19 pandemic on the Company and its current or anticipated markets; and (iv) the other risks and uncertainties described herein, as well as the risks and uncertainties discussed from time to time in other reports and other public documents filed with the Securities and Exchange Commission (the âSECâ) by the Society. Additional information regarding these and other factors that may affect the Company’s expectations and projections can be found in its initial filings with the SEC, including its Prospectus filed on October 12, 2021 and amended on October 25, 2021. October 2021 and November 1, 2021. Documents filed with the SEC are publicly available on the SEC’s website at www.sec.gov. Any forward-looking statement we make in this press release is based solely on information currently available to Mainz Biomed and speaks only as of the date on which it is made. Mainz Biomed assumes no obligation to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, except as required by law. required.
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