At-home Colorectal Cancer Diagnostic Test Now Available Online in Germany
BERKELEY, US – MAINZ, Germany – DECEMBER 7th, 2021 — Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, is pleased to announce the launch of ColoAlert.de, an ecommerce store providing Germans direct access to its ColoAlert colorectal cancer (CRC) screening test. German residents unable to obtain timely CRC screening via in-person physician visits, will be able to order ColoAlert directly to their home and receive highly accurate results within a maximum of nine working days.
“In recent years, the largest decreases in CRC mortality have been in countries with long-standing screening programs, and we are excited to bring ColoAlert, a unique, easy-to-use diagnostic test that is highly efficacious to market,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “As we launch ColoAlert across Europe through partnerships with regional laboratories, we are mindful that the Coronavirus pandemic has made it difficult to access CRC testing via in-person physician visits. As such, we are excited to leverage our in-house lab in Mainz, Germany, to provide an efficient CRC screening alternative to ensure that anyone in the country interested in performing a test has access to a top-tier solution.”
This direct-to-patient program will utilize Mainz Biomed’s own, high-throughput, clinical lab based in Mainz, and be administered by in-house physicians. The Company’s clinical team will also be on hand to provide phone-based support to ensure a high level of patient care. In line with Mainz Biomed’s business strategy, it is expected that ColoAlert.de and other Company-owned online points of sale will eventually distribute orders for diagnostic tests to partner labs within the network, both within Germany and globally as further regulatory approvals are secured and member labs integrated.
Colorectal cancer is the second deadliest cancer in the European Union (EU), with approximately 170,000 people dying every year, out of a diagnosed population of 370,000. According to Digestive Cancers Europe*, if the European Union was able to diagnose more patients in stage 1 from the current 13% to 50%, 130,000 more lives could be saved per year and more than 3 billion € in healthcare budget savings could be generated every year, and possibly the same amount in social and work-related value.
ColoAlert detects colorectal cancer (CRC) via a simple-to-administer test with a sensitivity and specificity nearly as high as the invasive colonoscopy**. The test utilizes proprietary methods to analyze cell DNA for specific tumor markers combined with the fecal immunochemical test (FIT) and is designed to detect tumor DNA and CRC cases in their earliest stages. The product is CE-IVD marked (complying with EU safety, health and environmental requirements) and is transitioning to compliance with IVDR. The product is commercially available in a selection of countries in the European Union. Mainz Biomed currently distributes ColoAlert through a number of clinical affiliates. Once approved in the U.S., 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 second most lethal cancer in the U.S. and Europe, but also the most preventable with early detection providing survival rates above 90 %. Annual testing costs per patient are minimal, especially when compared to late-stage treatments of CRC which 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 U.S. with 52,980 resulting in death. Recent FDA decisions suggest that screening with stool DNA tests such as ColoAlert in the US should be conducted once every three years starting at age 45. Currently there are 112 million Americans aged 50+, a total that is expected to increase to 157 million within 10 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 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. ColoAlert is currently marketed across Europe. In the USA, Mainz Biomed will begin the clinical study and regulatory process in the first half of 2022 for U.S. FDA approval. Mainz Biomed’s product candidate portfolio 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, and the GenoStick technology, a platform being developed to detect pathogens on a molecular genetic basis.
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 Prospectus filed on October 12, 2021 and amended on October 25, 2021 and November 1, 2021. 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.