Mainz Biomed N.V. and Quest Diagnostics (NYSE:DGX) have entered into an agreement aimed at bolstering the commercialization of Mainz Biomed’s innovative NextGen screening test for colorectal cancer.
Quest Diagnostics will provide essential clinical trial laboratory services for Mainz Biomed’s ReconAAsense study. This prospective clinical study is set to enroll approximately 15,000 subjects across 150 sites within the United States. The goal is to generate robust data to support FDA validation of the NextGen test.
According to the World Cancer Research Fund, colorectal cancer (CRC) is the third most prevalent cancer worldwide, with over 1.9 million new cases reported in 2020. The U.S. Preventive Services Task Force recommends stool DNA-FIT (sDNA-FIT) tests every one to three years, starting at age 45. Despite these guidelines, roughly one-third of U.S. residents aged 50-75 have never been screened for colon cancer, representing a significant unmet need and a market opportunity exceeding $4.0 billion in the U.S.
ColoAlert Test
Mainz Biomed's ColoAlert test is a stool-based assay designed to detect colorectal cancer tumor DNA, aiding in the early identification of the disease. Utilizing polymerase chain reaction (PCR) technology, the test analyzes small DNA samples from stool to identify genetic mutations indicative of cancer. Preliminary data suggest promising sensitivity and specificity in detecting colorectal cancer, including advanced adenomas.
eAArly DETECT 2 Study
Mainz Biomed has initiated eAArly DETECT 2, a U.S. feasibility study, to evaluate the company's next-generation colorectal cancer (CRC) test. This test integrates proprietary mRNA biomarkers, an AI-developed algorithm, and a FIT test, over a population of approximately 2,000 average-risk patients. The study aims to validate previous feasibility studies' results, which included average and identified-risk patients.
The eAArly DETECT 2 study is expected to complete enrollment in the second half of 2025, with topline results targeted for the fourth quarter of 2025. Based on the study's outcome, Mainz Biomed intends to finalize its protocols for ReconAAsense, the Company's U.S. pivotal study, which is on track to initiate in 2026. This next-generation CRC test will not only detect cancerous polyps with a high degree of accuracy but can potentially prevent the disease through early detection of precancerous adenomas.
Executive Commentary
Guido Baechler, Chief Executive Officer of Mainz Biomed, expressed enthusiasm about the collaboration, stating, “We are excited by the opportunity to work with Quest Diagnostics. 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.”
Baechler also commented on the eAArly DETECT 2 study, saying, “The launch of eAArly DETECT 2 is an important milestone for the Company as it enables us to accelerate the timeline to evaluate the potential of these biomarkers to be incorporated into our U.S. pivotal study, which is on track to initiate in 2026. The potential inclusion of advanced adenomas in Mainz BioMed's next generation CRC screening test will represent a transformational advancement in self-administered CRC screening. Precise detection of advanced adenomas as well as early-stage CRC supports our mission to transform colorectal cancer screening practices and reduce global cancer mortality rates.”
Future Implications
Assuming FDA approval, Mainz Biomed will grant Quest Diagnostics the option to exercise semi-exclusive rights to provide testing services based on the test kit for an eighteen-month period. This collaboration seeks to address the critical gap in colorectal cancer screening and improve patient access to early detection methods.
