Colorectal cancer remains a significant health threat, ranking as the second leading cause of cancer death in the United States. With over 100,000 cases diagnosed in 2024 alone, the need for more effective detection methods is evident. Mainz Biomed (NASDAQ: MYNZ), a German company with U.S. offices in Berkeley, California, is aiming to address this pressing issue with a new diagnostic test that promises to be nearly twice as sensitive as existing solutions.
In a recent interview, Mainz's CFO Bill Caragol highlighted the company's efforts to gain FDA Breakthrough Device Designation for their innovative colorectal cancer detection test. This non-invasive test utilizes a portfolio of mRNA biomarkers to detect precancerous polyps at a sensitivity rate significantly higher than current market options.
Traditional methods for detecting colorectal cancer, such as colonoscopies, have been standard practice since 1969. While effective, these procedures are invasive and often uncomfortable for patients. In 2014, the FDA approved the fecal immunochemical test (FIT), which analyzes DNA to detect advanced adenomas, pre-cancerous polyps that are strong indicators of future colorectal cancer risk. However, blood-based tests, another available option, have been criticized for their lower effectiveness and cost-efficiency compared to stool-based tests.
Mainz's new test, an enhancement of their existing ColoAlert® product, has shown promising results. Clinical studies conducted between 2023 and 2024 revealed that the test has an accuracy rate above 80%, a significant improvement over the approximately 40% detection rate of advanced adenomas by competitor tests. This improvement could potentially reduce the number of missed cases by up to 60%.
The next-generation FIT test developed by Mainz is further enhanced with artificial intelligence and machine learning algorithms that identify mRNA biomarkers, allowing for more precise early detection of colorectal cancer. The company describes this as a new gold standard for non-invasive detection of advanced adenomas.
Looking ahead, Mainz plans to conduct an FDA pre-market approval study in 2025. A key aspect of this study will be the distribution of the next-generation test kit through existing FDA-approved national reference testing laboratories. This approach contrasts with other products currently on the market, which are tightly controlled by the companies that manufacture, distribute, and analyze the tests.
Caragol emphasized the strategic importance of partnering with larger companies, including PCR providers and national reference labs, to facilitate both the pre-market approval study and the commercial distribution of the test kits. These partnerships will be crucial for Mainz's go-to-market strategy, helping to raise awareness among physicians and healthcare professionals about the benefits of their mRNA-powered test.
The potential market impact for Mainz is substantial. The U.S. market for colorectal screening is valued at over $30 billion annually, with the global market being double that figure. Competing with significant players like Exact Sciences Corp. (NASDAQ: EXAS), which holds about a 10% share of U.S. sales, Mainz has a considerable opportunity to capture a significant market share if their test receives FDA approval.
Beyond colorectal cancer, Mainz envisions expanding its product line to include test kits for other gastrointestinal cancers, such as pancreatic cancer, further broadening their market potential.
