Mainz Biomed Announces Live Launch of ColoAlert® with Marylebone Laboratory in the United Kingdom

Collaborative Partnership Strengthens Mainz Biomed's Mission to Combat Colorectal Cancer, Saving Lives through Advanced Diagnostics

BERKELEY, US – MAINZ, Germany – August 01, 2023 — Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today that London-based Marylebone Laboratory (Marylebone Lab Ltd) has introduced ColoAlert®, Mainz Biomed’s flagship product—a highly effective and user-friendly at-home detection test for colorectal cancer (CRC) - to its extensive UK and international customer base.

Further strengthening Mainz Biomed’s global network of esteemed laboratory partners, the collaboration marks another significant milestone in the Company’s mission to combat colorectal cancer (CRC) and save lives through advanced diagnostics. Colorectal cancer remains a critical health concern, with approximately 43,000 diagnoses and 16,800 deaths occurring each year in the UK alone. This equates to an average of 46 lives lost every day.

With a population of 67 million people, the UK, presents a substantial market for CRC screening. Specifically, within the age groups of 40 to 49 years and 50 to 75 years, there are approximately 8.4 million and 20.0 million individuals respectively. Additionally, there are 6.2 million individuals aged over 75. With a recommended frequency of CRC screening once every two years for patients aged 50 to 74, ColoAlert® represents a pivotal tool in the fight against this devastating disease. Considering these figures, the addressable UK market for ColoAlert® amounts to a staggering 34.6 million potential users.

Mainz Biomed is delighted to collaborate with Marylebone Laboratory, which recently expanded its presence in London, under the Marylebone Diagnostic Centre brand where it provides a comprehensive range of screening and diagnostic testing services. Marylebone Laboratory brings extensive expertise in NGS (Next-Generation Sequencing) and PCR (Polymerase Chain Reaction)-based molecular genetic testing. Its focus on innovative methodologies allows for tailored solutions to individual customers as well as larger organizations and ensures the delivery of state-of-the-art genetic-based testing services.

“With our significant experience in both NGS and PCR based molecular genetic testing, we are thrilled to offer ColoAlert® to our UK-based and international customer network,” said Thomas Bianchi, Director of the Centre. “Colorectal cancer is the fourth most common cancer in the UK and the third worldwide and ColoAlert®’s unique genetic-based solution has the potential to provide a step change in how we’re able to provide life-changing early diagnosis.”

Darin Leigh, Chief Commercial Officer of Mainz Biomed, expressed his excitement about this partnership, stating “With Marylebone, we are pleased that we have found a strong strategic partner in the UK market. The organization is committed to bringing the very best CRC screening solutions to the UK population to reduce the number of late CRC diagnoses, thereby increasing patient survival and reducing the burden of medical treatment.”

About ColoAlert®

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.