ColoAlert® will be offered to an addressable market of 6 million patients through 15 laboratories.
BERKELEY, US – MAINZ, Germany – June 20, 2023 — Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, is excited to announce the addition of Bioclinica to its esteemed network of laboratory partners. Bioclinica will play a crucial role in supporting the commercialization efforts of ColoAlert, Mainz Biomed’s flagship product—a highly effective and user-friendly at-home detection test for colorectal cancer (CRC). This strategic collaboration marks another milestone in Mainz Biomed’s mission to revolutionize the diagnosis and prevention of life-threatening diseases, particularly CRC, which continues to be the second most lethal cancer in Europe.
“We are delighted to welcome Bioclinica as a ColoAlert partner,” stated Darin Leigh, Chief Commercial Officer of Mainz Biomed. “In executing our commercial strategy, we remain steadfast in aligning ourselves with laboratories that share our unwavering dedication to introducing cutting-edge diagnostic tests capable of making a profound impact on the treatment and prevention of critical diseases like CRC. Early detection is paramount in enhancing patient survival rates, and our partnership with Bioclinica in Romania exemplifies our commitment to this cause.”
ColoAlert’s unique business model sets it apart from traditional methodologies in the industry. Rather than operating a single facility, Mainz Biomed has chosen to collaborate with third-party laboratories for the processing of ColoAlert test kits. This approach allows Mainz Biomed to leverage the expertise and resources of established organizations like Bioclinica, ensuring widespread availability and accessibility of the test across Europe and select international markets. According to United Nations, Department of Economic and Social Affairs population statistics, ColoAlert screening has the potential to benefit over 6 million individuals aged between 50 and 74 years in Romania where the CRC incidence rates are among the highest in Europe.
Mainz Biomed is providing ColoAlert to Bioclinica under the standard terms of the Company’s partnership agreements. Bioclinica is a leading supplier of healthcare products in Romania, with over 25 years of experience in medical diagnostics. Through its 15 associated laboratories and 146 collection points, Bioclinica provides state-of-the-art diagnostics to the Romanian population. In the coming weeks, Mainz Biomed will work with Bioclinica to prepare and launch co-marketing activities to ensure a successful commercial launch in these markets.
ColoAlert®, Mainz Biomed’s flagship product, delivers high sensitivity and specificity in a user-friendly, at-home colorectal cancer (CRC) screening kit. This non-invasive test can be indicative of tumors as determined by analyzing tumor DNA, offering better early detection than fecal occult blood tests (FOBT). Based on PCR-technology, ColoAlert® detects more cases of colorectal cancer than other stool tests and allows for an earlier diagnosis (Gies et al., 2018). The product is commercially available in select EU countries through a network of leading independent laboratories, corporate health programs and via direct sales. To receive marketing approval in the US, ColoAlert® will be evaluated in the FDA-registration trial ‘ReconAAsense.’ 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
Colorectal cancer (CRC) is the third most common cancer globally, with more than 1.9 million new cases reported in 2020, according to World Cancer Research Fund International. The US Preventive Services Task Force recommends that screening with stool DNA tests such as ColoAlert® should be conducted once every three years starting at age 45. Each year in the US, 16.6 million colonoscopies are performed. However, roughly one-third of US residents aged 50-75 have never been screened for colon cancer. This gap in screening represents a $4.0B+ total market opportunity in the US.
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 based on real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in stool samples. ColoAlert® is currently marketed across Europe. The Company is 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. To learn more, visit mainzbiomed.com or follow us on LinkedIn, Twitter and Facebook.
For media inquiries, please contact email@example.com
MC Services AG
Anne Hennecke/Caroline Bergmann
+49 211 529252 20
In the US:
+1 416 628 7441
For investor inquiries, please contact firstname.lastname@example.org
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 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.