Mainz Biomed Processes First Patients from Colorectal Cancer Screening Campaign Through its Corporate Health Portal in Partnership with Zöeller-Kipper

Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today initial results from its colorectal cancer (CRC) screening campaign through its BGM (“betriebliches Gesundheitsmanagement”) partnership with Zöeller-Kipper GmbH, part of the Zöeller group with more than 2,500 employees. In April 2023, Zöeller-Kipper selected ColoAlert®, Mainz Biomed’s highly efficacious and easy-to-use screening test for CRC, for its corporate health program.

“We are incredibly pleased with these early results, as outcomes like these indicate what the future holds when patients have increased access to easy, convenient and affordable screening,” said Guido Baechler, Chief Executive Officer of Mainz Biomed. “As we expand the reach of ColoAlert, I am thankful for the dedication of our team members and partners, like Zöeller-Kipper, for spreading the importance of early detection screening as CRC is the second most lethal cancer nationally, with almost 73,000 new cases diagnosed each year in Germany.”

Using Mainz Biomed’s online portal, Zöeller-Kipper employees registered to be mailed the ColoAlert test. Once the sample was received and processed, confidential test results were sent back to the employee through the portal, along with an explanation of the results. If an employee had approved for a physician to be notified of test results, then the doctor could directly follow-up with the patient. As part of its commitment to the BGM program, Mainz Biomed provided education to employees and physicians on CRC and recommendations for next steps.

“Mainz Biomed made it easy for us to quickly implement ColoAlert as one of our BGM options,” said Irina Riffel, Head of HR of Zöeller-Kipper. “Our employees are able to readily access the patient portal, request a kit and securely receive their results within five days. Their feedback about the process is positive and we are pleased to offer them this test, as early CRC detection and diagnosis can lead to better treatment options and improved outcomes. Ensuring the health and well-being of our employees is paramount.”

“We would like to thank Zöeller-Kipper for this successful collaboration and their dedication to give their employees access to state-of-the-art CRC screening with ColoAlert,” added Mr. Baechler. “We look forward to participating in more programs like this with other companies throughout Germany and Europe.”

About ColoAlertColoAlert®, 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 CancerColorectal 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 NVMainz 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.

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