Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced an agreement with Quest Diagnostics (NYSE:DGX), a leading provider of diagnostic information services, to support commercialization of Mainz Biomed’s NextGen screening test for colorectal cancer.
Mainz Biomed’s stool-based ColoAlert test is designed to detect colorectal cancer tumor DNA to aid in identifying colorectal cancer in early stages. Through polymerase chain reaction (PCR) technology, a small sample of DNA can be examined through a patient’s stool sample to identify genetic mutations that may lead to a cancer diagnosis. Mainz Biomed’s ColoAlert test has shown promising sensitivity and specificity in identifying colorectal cancer, including advanced adenomas, in preliminary data.
Quest will provide clinical trial laboratory services for Mainz Biomeds’s ReconAAsense study, a prospective clinical study that will include approximately 15,000 subjects from 150 sites across the United States to develop data supporting FDA validation of the NextGen test. In addition, Mainz Biomed will provide Quest with the option to exercise semi-exclusive rights to provide testing services based on the test kit for an eighteen-month period, assuming its approval by the FDA.
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. The US Preventive Services Task Force recommends that screening with stool DNA-FIT (sDNA-FIT) tests should be conducted once every one to three years starting at age 45. 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. Offering alternative screening modalities, such as sDNA-FIT, may help bridge this gap.
“We are excited by the opportunity to work with Quest Diagnostics,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “Quest is a leader in cancer diagnostics and knows how to scale these innovations to make them broadly accessible to patients in need. With their support, we are positioned to advance commercial development of our ColoAlert test in order to help more patients gain access to quality screening.”
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. ColoAlert® is marketed across Europe. The Company is currently 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 based on real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in stool samples. To learn more, visit mainzbiomed.com.
About Quest Diagnostics
Quest Diagnostics works across the healthcare ecosystem to create a healthier world, one life at a time. We provide diagnostic insights from the results of our laboratory testing to empower people, physicians and organizations to take action to improve health outcomes. Derived from one of the world’s largest databases of de-identifiable clinical lab results, Quest’s diagnostic insights reveal new avenues to identify and treat disease, inspire healthy behaviors and improve healthcare management. Quest Diagnostics annually serves one in three adult Americans and half the physicians and hospitals in the United States, and our more than 50,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives and create a healthier world. www.QuestDiagnostics.com.
