Mainz Biomed Expands European Commercial Footprint and Enters Markets in Spain and UK
Mainz Biomed, a molecular genetics diagnostic company, announced new partnerships with Marylebone Laboratory and Instituto de Microecologia to distribute its flagship product, ColoAlert, for colorectal cancer detection. This collaboration enables a broader commercialization of the at-home test across England and Spain, targeting a market of 26 million patients in Spain and 9 million in London. The company aims to enhance early detection of colorectal cancer, the second most lethal cancer in Europe, significantly improving survival rates. The test is CE-IVDR marked and already marketed in several EU countries, with plans for US regulatory approval.
- Establishment of partnerships with Marylebone Laboratory and Instituto de Microecologia enhances distribution across England and Spain.
- ColoAlert targets a significant market with 26 million potential patients in Spain and 9 million in London.
- ColoAlert is CE-IVDR marked, indicating compliance with EU standards for health and safety.
- The company is focused on early detection of colorectal cancer, improving patient survival rates.
- None.
Continued roll-out in Europe with onboarding of new lab partners
BERKELEY, Calif. and MAINZ, Germany, Feb. 15, 2023 (GLOBE NEWSWIRE) -- Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today the establishment of commercial partnerships for ColoAlert with Marylebone Laboratory (Marylebone Lab LTD) and Instituto de Microecologia, two leading independent laboratories covering England and Spain. ColoAlert, Mainz Biomed’s flagship product, a highly efficacious and easy-to-use, at-home detection test for colorectal cancer (CRC), is currently being commercialized across Europe and in select international markets via a differentiated business model of partnering with third-party laboratories for test kit processing versus the traditional methodology of operating a single facility.
“It’s a pleasure to welcome Marylebone Lab and Instituto de Microecologia to our network of laboratory partners,” commented Darin Leigh, Chief Commercial Officer of Mainz Biomed. “As we execute our commercial strategy, we are steadfast in aligning with laboratories who share our passion for bringing to market premier diagnostic tests that have the potential to dramatically impact the treatment and prevention of deadly diseases such as CRC, which remains the second most lethal cancer in Europe, and for which early detection plays a critical role in patient survival.”
The addressable market in Spain is estimated at 26 million patients and at 9 million patients in the greater London region. Mainz Biomed is providing ColoAlert to Marylebone and Instituto de Microecologia under the standard terms of the Company’s partnership agreements. In the coming weeks, Mainz Biomed will work with both partners to complete the necessary technical and co-marketing activities to ensure a successful commercial launch in these markets.
About ColoAlert
ColoAlert detects colorectal cancer (CRC) via a simple-to-administer test with a high level of sensitivity and specificity (Dollinger MM et al., 2018). The test utilizes proprietary methods to analyze cell DNA for specific tumor markers combined with the fecal immunochemical test (FIT). It is designed to detect tumor DNA and CRC cases in their earliest stages. The product is CE-IVDR marked (complying with EU safety, health and environmental requirements) and commercially available in a selection of countries in the European Union and the United Arab Emirates. Mainz Biomed currently distributes ColoAlert through a number of clinical affiliates. Once approved in the US, the Company’s commercial strategy is to establish scalable distribution through a collaborative partner program with regional and national laboratory service providers across the country.
About Colorectal Cancer
According to the Centers for Disease Control and Prevention (CDC), colorectal cancer (CRC) is the second most lethal cancer in the U.S. and Europe, but also the most preventable, with early detection providing survival rates above
About Mainz Biomed NV
Mainz Biomed develops market-ready molecular genetic diagnostic solutions for life-threatening conditions. 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 and the United Arab Emirates. The Company is currently running a pivotal FDA clinical study for US regulatory approval. Mainz Biomed’s product candidate portfolio also includes PancAlert, an early-stage pancreatic cancer screening test based on real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in stool samples. To learn more, visit mainzbiomed.com or follow us on LinkedIn, Twitter and Facebook.
For media inquiries, please contact press@mainzbiomed.com
In Europe:
MC Services AG
Anne Hennecke/Caroline Bergmann
+49 211 529252 20
mainzbiomed@mc-services.eu
In the US:
Spectrum Science
Melissa Laverty/Valerie Enes
+1 540 272 6465
mainz@spectrumscience.com
For investor inquiries, please contact info@mainzbiomed.com
Forward-Looking Statements
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”, “believe”, “expect”, “estimate”, “plan”, “outlook”, and “project” and other similar expressions that predict or indicate future events or trends or that 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. As a result, caution must 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) the failure to meet projected development and related targets; (ii) changes in applicable laws or regulations; (iii) the effect of the COVID-19 pandemic on the Company and its current or intended markets; and (iv) other risks and uncertainties described herein, as well as those 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 Company. Additional information concerning these and other factors that may impact the Company’s expectations and projections can be found in its initial filings with the SEC, including its annual report on Form 20-F filed on May 5, 2022. The Company’s SEC filings are available publicly on the SEC’s website at www.sec.gov. Any forward-looking statement made by us in this press release is based only on information currently available to Mainz Biomed and speaks only as of the date on which it is made. Mainz Biomed undertakes no obligation to publicly update any forward-looking statement, 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.
FAQ
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