Mainz Biomed joins a collective of physicians, medical professionals, laboratories and health organizations as part of the international initiative Colorectal Cancer Awareness Month
BERKELEY, Calif. and MAINZ, Germany, March 02, 2022 (GLOBE NEWSWIRE) — Mainz Biomed NV (NASDAQ: MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetic diagnostics company specializing in the early detection of cancer, announced today that it will join, together with its German partner laboratories, a collective of doctors, health professionals, laboratories and health organizations in a national awareness campaign for colorectal cancer (CRC) screening .
“CRC is the second most common and deadliest cancer in the world. More than 500,000 European citizens are expected to be diagnosed this year alone*,” said Guido Baechler, Managing Director of Mainz Biomed. “As early detection of the disease is imperative for successful treatment, international initiatives such as CRC Awareness Month in March are an invaluable way to raise awareness and literally save lives around the world. We are very proud to partner with so many other purpose-driven organizations and play our part in eradicating this horrible disease.
As part of CRC Awareness Month, throughout March, Mainz Biomed will join a coordinated campaign with the collaboration of government and private organizations across Germany, designed to draw attention to CRC , provide valuable information to citizens and encourage more people to undergo proactive screening.
Using multiple advertising channels, patients will be encouraged to visit www.gemeinsam-gegen-darmkrebs.de (Together Against Colorectal Cancer), an online resource that provides detailed information on CRC screening as well as a risk calculator able to determine their risk profile for the disease and suggest appropriate follow-up measures. Patients will also be able to find information about local physicians, testing labs, and schedule a free phone consultation with Mainz Biomed in-house physicians.
Colorectal Cancer Month is an internationally recognized celebration designed to raise awareness of CRC screening. Originally created by Presidential Proclamation signed by President Clinton on February 29, 2000, it has become a catalyst for governments and organizations around the world to communicate new research and advice, and to host special events designed to help engage their local communities in raising awareness of the disease.
ColoAlert detects colorectal cancer (CRC) via a simple to administer test with almost as high sensitivity and specificity as invasive colonoscopy*. The test uses proprietary methods to analyze cellular DNA for specific tumor markers combined with the Fecal Immunochemistry Test (FIT) and is designed to detect tumor DNA and cases of CRC in their early stages. The product is CE-IVD marked (meets EU safety, health and environmental requirements) and is in the process of transitioning to IVDR compliance. The product is commercially available in selected European Union countries. Mainz Biomed currently distributes ColoAlert through a number of clinical affiliates. 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 the ColoFuture study
The ColoFuture study is an international clinical trial evaluating more than 600 patients (women or men) between the ages of 40 and 85 at two participating centers in Norway and two in Germany. Subjects are invited to potentially participate in the trial when referred for colonoscopy (pre-inclusion) to screen for CRC or global diagnostic analysis. Those who agree to provide a stool sample prior to the procedure will be eligible to participate. Inclusion criteria are based on one of the following diagnostic findings: CRC, advanced precancerous lesions of the colon, or normal colon. Then, each patient result will compare the observations recorded during the colonoscopy to the results of the ColoAlert test which incorporates the new biomarkers. The primary endpoints of the study are to determine sensitivity and specificity rates for CRC with ColoAlert plus the novel mRNA biomarkers. There are several secondary endpoints for evaluating the modified ColoAlert test, including determination of sensitivity for AA lesions in the colon, specificity for advanced precancerous lesions in the colon, and specificity for no colorectal finding ( normal colon). The company expects to complete recruitment in the second half of 2022 and aims to report study results in early 2023.
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 late-stage CRC treatments that cost patients an average of $38,469 per year. The American Cancer Society estimates that in 2021 there will be approximately 149,500 new cases of colon and rectal cancer in the United States, with 52,980 resulting in death. Recent FDA rulings suggest that screening with stool DNA tests such as ColoAlert in the US should be done once every three years starting at age 45. years. Appropriately testing these US-based 50+ populations every three years, as prescribed, 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 lead 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 an FDA clinical study and submission process expected to launch in the first half of 2022 for regulatory approval in the United States. Mainz Biomed’s portfolio of product candidates includes PancAlert, an early detection test for pancreatic cancer based on real-time, multiplex polymerase chain reaction (PCR)-based detection of molecular genetic biomarkers in stool specimens, and GenoStick technology, a platform under development to detect pathogens on a molecular genetic basis.
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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 can be identified by the use of words such as ” anticipate”, “believe”, “expect”, “estimate”, “plan”, “outlook” and “project” and other similar expressions which predict or indicate future events or trends or which are not statements of historical matters. These forward-looking statements reflect the current analysis of existing information and are subject to various risks and uncertainties. Accordingly, caution should be exercised when relying on forward-looking statements. Due to known risks and unknown, actual results could differ materially from the Company’s expectations or projections. The following factors, among others, could cause the Actual results differ materially from those described in these forward-looking statements: (i) failure to achieve projected developments 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) other risks and uncertainties described herein, as well as the risks and uncertainties discussed from time to time in other reports and other public filings with the Securities and Exchange Commission (the “SEC”) by the society. Additional information regarding these and other factors that could affect the Company’s expectations and projections may be found in its initial filings with the SEC, including its registration statement on Form F-1 filed. on January 21, 2022. The Company’s filings with the SEC are publicly available on the SEC’s website at www.sec.gov. Any forward-looking statements we make in this press release are based solely on information currently available to Mainz Biomed and speak only as of the date on which they are made. Mainz Biomed undertakes no obligation to update publicly any forward-looking statements, 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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