Mainz Biomed Announces Collaboration with Fugene Genetics in Israel
Israel has one of the highest screening compliance rates in the world with over one million people being screened each year
BERKELEY, US – MAINZ, Germany – JULY 18, 2023 — Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announces today its commercial partnership for ColoAlert with Fugene Genetics, a renowned genetic testing service provider based in Israel. Fugene Genetics, established in 2008, offers a wide range of advanced genetic testing services to private clients, health organizations, hospitals, and genetic institutes throughout the country.
ColoAlert is Mainz Biomed’s flagship product, an effective and user-friendly at-home detection test for colorectal cancer (CRC). The test is currently being rolled out in Europe and selected international markets through a unique business model of partnering with third-party laboratories and experienced distribution partners for test kit processing, as opposed to operating a single facility, which is the traditional approach.
“We continue to make great strides in growing the market access to ColoAlert around the globe, aligning with experienced partners that have significant expertise in their national markets and are able to meet the strong clinical need for differentiated products,” said Darin Leigh, Chief Commercial Officer for Mainz Biomed. “Fugene Genetics has a highly successful track record of introducing novel molecular diagnostic products into Israel using its extensive commercial network and relationships with leading laboratories.”
Israel has one of the highest screening compliance rates in the world with over one million people being screened each year. It is expected that over 3.5 million adults could benefit from the availability of ColoAlert in Israel. Mainz Biomed will provide ColoAlert to Fugene Genetics under their standard partnership agreements. In the coming weeks, the two companies will collaborate on co-marketing activities to ensure a successful commercial launch in Israel.
"We are thrilled to collaborate with Mainz Biomed on the commercial partnership for ColoAlert, an innovative early screening test for colon cancer," said Noa Rinzler Diwan, PhD, CEO of Fugene Genetics. "ColoAlert's effectiveness and user-friendly nature make it a valuable addition to our genetic testing services in Israel. With our extensive commercial network and strong relationships with healthcare providers, we are well positioned to introduce ColoAlert and promote early detection of colon cancer among our clients. This partnership aligns with our commitment to delivering cutting-edge genetic testing solutions and improving healthcare outcomes. We are excited about the opportunity to work closely with Mainz Biomed to ensure a successful commercial launch and make a significant impact on colon cancer screening in Israel."
About ColoAlert®
ColoAlert, Mainz Biomed's flagship product, offers high sensitivity and specificity as an easy-to-use at-home screening kit for colorectal cancer (CRC). This non-invasive test analyzes tumor DNA and provides better early detection than fecal occult blood tests (FOBT). Utilizing PCR-technology, ColoAlert has demonstrated superior performance in detecting colorectal cancer compared to other stool tests, enabling earlier diagnosis (Gies et al., 2018). The product is currently available in select EU countries through independent laboratories, corporate health programs, and direct sales. In the US, ColoAlert is undergoing evaluation in the FDA-registration trial 'ReconAAsense' for marketing approval. Mainz Biomed's commercial strategy for the US market involves establishing scalable distribution through collaborations with regional and national laboratory service providers across the country.
About Colorectal Cancer
Colorectal cancer (CRC) is the third most common cancer globally, with over 1.9 million new cases reported in 2020 according to the World Cancer Research Fund International. The US Preventive Services Task Force recommends stool DNA tests, such as ColoAlert, to be conducted every three years starting at age 45. Despite this recommendation, approximately one-third of US residents aged 50-75 have never been screened for colon cancer, representing a significant untapped market opportunity estimated at over $4.0 billion in the US alone.
About Mainz Biomed NV
Mainz Biomed NV specializes in developing market-ready molecular genetic diagnostic solutions for life-threatening conditions. ColoAlert is the company's flagship product, offering 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. Currently available in Europe, Mainz Biomed is conducting a pivotal FDA clinical study for regulatory approval in the US. In addition to ColoAlert, Mainz Biomed's product candidate portfolio includes PancAlert, an early-stage pancreatic cancer screening test. For more information, please visit mainzbiomed.com or follow us on LinkedIn, Twitter and Facebook.
