Colorectal cancer is a significant health threat in America, claiming the lives of 50,000 people annually. Despite the high stakes, early detection can lead to a 90% survival rate after five years, yet only 40% of cases are detected at an early stage. Several barriers, including lack of awareness, affordability, and accessibility, contribute to low screening rates.
Two primary methods are currently used for colorectal cancer screening: colonoscopies and fecal occult blood tests (FITS). Colonoscopies, though precise, are invasive and require extensive preparation. FITS are more convenient but can only detect the disease in its later stages. Recognizing these limitations, Mainz Biomed (NASDAQ: MYNZ) has developed ColoAlert, a non-invasive, early detection test that aims to address these issues effectively.
ColoAlert utilizes advanced tumor DNA analysis to identify both bleeding and non-bleeding tumors, offering a significant advantage over traditional fecal occult blood tests. This capability is crucial because colorectal cancer often develops from polyps over time. Early detection of these polyps can greatly reduce the risk of them becoming cancerous.
Colorectal cancer originates from genetic mutations in intestinal cells, which are continuously excreted through stool. ColoAlert analyzes these samples for four key tumor markers: KRAS mutation, BRAF mutation, total human DNA, and occult blood. This comprehensive analysis enables ColoAlert to detect 85% of colorectal cancers, often at very early stages, a capability that competing at-home tests lack.
The potential market for ColoAlert is substantial. Currently, 37 million people in the U.S. undergo colorectal cancer screening annually. This number could rise to 52 million within the next decade due to an aging population. In the U.S., there are 112 million people over the age of 50, a figure expected to grow to 157 million in the next ten years. With the FDA recommending that screenings start at age 45, the market opportunity for ColoAlert could expand even further, potentially reaching $4 billion in the U.S. and $6 billion in Europe.
ColoAlert has already demonstrated superior accuracy compared to other at-home tests. A recent multicentric study involving 566 patients found that ColoAlert, with a sensitivity of 85% and a specificity of 92%, was the most accurate among non-invasive screening methods. Further testing is planned to validate its effectiveness, but early indications are promising.
Ease of use is another significant advantage of ColoAlert. The test kit can be administered at home within five minutes, with clear instructions, a stool collector, and a pre-labeled shipping package. Results are typically available within a few days. Unlike its competitor, ColoGuard, ColoAlert requires only a small sample size, contributing to a 98% patient satisfaction rate.
Colorectal cancer is the third most commonly diagnosed cancer and a leading cause of cancer-related deaths globally. Early detection can make a critical difference, yet many people forego screening each year. Mainz Biomed aims to change this with ColoAlert, potentially lowering the incidence of colorectal and other gastrointestinal cancers.
