Mainz Biomed's ColoAlert: A Rising Star in Colorectal Cancer Screening

Mainz Biomed NV (NASDAQ: MYNZ) is emerging as a formidable player in the colorectal cancer screening market, sharing the spotlight with industry giant Exact Sciences Corp. (NASDAQ: EXAS). Both companies are revolutionizing the way colorectal cancer, which kills 50,000 people each year, is detected, offering non-invasive, at-home screening solutions. Mainz Biomed’s ColoAlert and Exact Sciences’ Cologuard are leading the charge in this critical healthcare sector.

ColoAlert, Mainz Biomed’s flagship product, utilizes tumor DNA analysis to detect bleeding and non-bleeding tumors, offering an early detection method that the company claims outperforms traditional fecal occult blood tests. Early detection is crucial, as colorectal cancers typically develop from polyps that grow over time. If caught early, the survival rate after five years is 90% for colorectal cancer.

On the other hand, Exact Sciences’ Cologuard identifies colorectal neoplasia-associated DNA markers and occult hemoglobin in human stool, also touting superior accuracy over blood tests. Both companies report high accuracy rates and customer satisfaction, but the similarities largely end there. Exact Sciences, with a market cap of $7 billion, significantly dwarfs Mainz Biomed’s $12.6 million market cap. Exact Sciences stock trades at around $42 a share, while Mainz Biomed trades at under $1.00 a share.

Despite these differences, Mainz Biomed has shown promising growth. Since its market entry in 2018, sales of ColoAlert have been growing at double-digit rates, with revenue increasing 69% year-over-year in 2023. The company is now preparing to bring ColoAlert to the U.S. market. Currently under evaluation by the Food and Drug Administration, ColoAlert is part of the ReconAAsense clinical study, which involves around 15,000 subjects from 150 sites across the United States. The study results, pivotal for FDA approval, are expected next year. If approved, Mainz Biomed plans to establish scalable distribution through a collaborative partner program with regional and national laboratory service providers across the country.

ColoAlert has demonstrated impressive accuracy and ease of use. According to the company, ColoAlert detects 85% of colorectal cancer cases, often in the early stages. A multicentric study involving 566 patients found that with a sensitivity of 85% and a specificity of 92%, ColoAlert was the most accurate test among non-invasive screening methods. Mainz Biomed plans further testing to validate its screening effectiveness compared to existing market options.

The market potential for colorectal cancer screening is substantial. Currently, 37 million people in the U.S. are screened for colorectal cancer each year, a number that could increase to 52 million per year within ten years as the population ages. With 112 million Americans aged 50 and older, expected to rise to 157 million in the next decade, and 40% of those aged 50 to 75 never having been screened, the opportunity is significant. The FDA recommends starting screening at age 45 and conducting it every three years, further expanding the potential market for ColoAlert. Mainz estimates the U.S. market opportunity at $4 billion and the European market at $6 billion.

While Exact Sciences remains a larger entity, Mainz Biomed's innovative approach and potential FDA approval make it a company to watch. With the ability to transform colorectal cancer screening, Mainz Biomed's future in the U.S. market could significantly impact its growth trajectory, positioning it as a key player in the industry.