Results will impact ColoAlert profile for FDA submission
Brings ColoAlert to Gold Standard Status as the First Home Screening Test for Colorectal Cancer
BERKELEY, Calif. and MAINZ, Germany, Feb. 04 10, 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, today announced the launch of ColoFuture , an international clinical study to assess the potential for integrating a portfolio of novel mRNA biomarkers into ColoAlert, the Company’s highly effective and easy-to-use colorectal cancer detection test, which is marketed in Europe . The new gene expression (mRNA) biomarkers, for which we acquired an exclusive license option from the University of Sherbrooke in early January 2022, have demonstrated a unique ability to identify curable precancerous colon polyps, as well as the early-stage treatable colorectal cancer (CRC). The ColoFuture study will assess the effectiveness of these biomarkers in improving the technical profile of ColoAlert to expand its ability to include the identification of advanced adenomas (AA), a type of precancerous polyp often attributed to CRC, while increasing ColoAlert diagnostic sensitivity rate and specificity.
“The launch of the ColoFuture study is an exciting opportunity for the company, patients and medical communities, as the result could be a game-changer for the role ColoAlert will play in the prevention and treatment of CRC. We look forward to reporting the clinical results of the study by early 2023,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “In its current configuration, the test already represents a leading discretionary diagnostic option, and we are delighted with the commercial traction ColoAlert has achieved to date through our unique business model of partnering with third-party labs for the treatment of test kits. However, if the results of the study turn out to be positive, it will be a major milestone for the company, as it will cement ColoAlert’s position as the premier home diagnostic tool for this deadly form of cancer.
The exclusive option to license these mRNA biomarkers from the University of Sherbrooke is the result of the institution’s pioneering work in the field, where researchers tested a battery of new transcriptional biomarkers using samples of colon cancer and precancerous lesions. The results of these studies demonstrated that the five mRNA targets chosen by Mainz Biomed offered the highest sensitivity and specificity of detection. (Herring et al 2021).
The ColoFuture study is evaluating more than 600 patients, men and women, between the ages of 40 and 85 at two participating centers in Norway and two in Germany. Subjects will be invited to potentially participate in the trial when they are referred for a colonoscopy (pre-inclusion) to screen for CRC or a 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 be compared to recorded observations from the colonoscopy to results from 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 release study results in early 2023.
Mainz is currently bringing ColoAlert to market in Europe through its unique business model of partnering with third-party labs to process test kits versus the traditional methodology of operating a single facility. The Company is also preparing to initiate ColoAlert’s regulatory pathway for approval in the United States, and results from ColoFuture will potentially be incorporated into the design of the US clinical study.
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 partners. 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 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. year. 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.