BERKELEY, US – MAINZ, Germany – January 11, 2024 — Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in early cancer detection, re-affirms its collaboration with TestDNA at the upcoming 10th Gdańsk Gastroenterology Symposium on January 12th–13th, 2024. The companies joined forces to advance innovative colorectal cancer (CRC) detection in Poland and to increase treatment options as well as survival rates through early detection.
The 10th Gdańsk Gastroenterology Symposium gathers national Polish lecturers, scientists, and practitioners who will share the latest insights in gastroenterology, hepatology, and gastrointestinal endoscopy. Mainz Biomed and TestDNA will be present as exhibitor during the two day symposium, also they will open the second day of panel discussions.
Panel Discussion V – Diseases of the lower digestive tract:
Presentation: Colorectal Cancer – The Need for Earlier Detection
Speaker: Steve Quinn, VP of International Business Development, at Mainz Biomed
Further Speakers during the panel discussion: Prof. Ph.D. n. med. Jarosław Reguła, Prof. Ph.D. n. med. Agnieszka Dobrowolska, Med. Dr n. Tomasz Marek
Time: Saturday, January 13, 2024, 9:00 am CET
Location: Hotel Radisson, Długi Targ 19, 80-828 Gdańsk, Poland
According to Digestive Cancers Europe, Poland shows a particularly high need for reliable non-invasive screening methods, such as ColoAlert, with only about one in five patients willing to use colonoscopy for screening. The incidence of 19,000 new cases annually with approximately 12,000 CRC-related deaths confirms the need for at-home screening tests with good early stage detection. The addressable market in Poland is estimated at 21 million patients.
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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 (Dollinger 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 N.V.
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.
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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 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 April 7, 2023. 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.