Mainz Biomed NV (NASDAQ: MYNZ) is making waves in the colorectal cancer screening market with its at-home test, ColoAlert. This development is particularly noteworthy as colorectal cancer claims 50,000 lives annually in the United States. Unlike traditional, invasive screening methods, ColoAlert offers a non-invasive alternative, making early detection more accessible and less uncomfortable.
ColoAlert identifies bleeding and non-bleeding tumors through tumor DNA analysis, which the company claims offers superior early detection compared to fecal occult blood tests. This is crucial as colorectal cancer often develops from polyps that can become cancerous over time. Early detection dramatically improves survival rates, with a five-year survival rate of 90% if caught early.
While Mainz Biomed is a smaller player compared to Exact Sciences Corp. (NASDAQ: EXAS), which has a market cap of $7 billion, Mainz's market cap stands at $12.6 million. Despite this disparity, Mainz has shown impressive growth. Its revenue for ColoAlert increased by 69% year-over-year in 2023, and further growth is anticipated.
Mainz is also preparing to introduce ColoAlert to the U.S. market, pending FDA approval. The test is currently under evaluation in a pivotal clinical study involving approximately 15,000 subjects across 150 sites in the United States. The results, expected next year, could be a significant catalyst for the company's growth if FDA approval is granted. The company plans to establish scalable distribution through partnerships with regional and national laboratory service providers.
Accuracy and ease of use are among ColoAlert's strong points. The test detects 85% of colorectal cancer cases, often in the early stages. A recent multicentric study involving 566 patients found ColoAlert to be the most accurate among non-invasive screening methods, with a sensitivity of 85% and a specificity of 92%. Further testing is planned to validate these results, potentially positioning ColoAlert as a reliable supplement to colonoscopy screening.
The market opportunity for ColoAlert is substantial. Currently, 37 million people in the U.S. get screened for colorectal cancer annually. This number could rise to 52 million within a decade as the population ages. The U.S. population aged 50 and above is expected to grow from 112 million to 157 million in the next ten years. Notably, about 40% of Americans aged 50 to 75 have never been screened for colorectal cancer. The FDA recommends starting screening at age 45, which could further expand the market for ColoAlert. Mainz estimates the U.S. market opportunity at $4 billion and the European market at $6 billion.
Colorectal cancer remains a deadly disease, but advancements like ColoAlert are reshaping the market. While Mainz Biomed is currently smaller than Exact Sciences, its potential for growth, especially with pending FDA approval, makes it a company worth watching.
