Early Detection of Colorectal Cancer Could Revolutionize Survival Rates, Says Mainz Biomed

Colorectal cancer is a leading cause of death in America, killing 50,000 people each year. However, early detection could drastically improve survival rates, with a five-year survival rate of 90% if the cancer is caught early. Despite these favorable odds, only about four in 10 colorectal cancers are detected at an early stage.

The low early detection rate is attributed to several factors, including lack of awareness, affordability issues, and limited access to screening. Current standard screenings, such as colonoscopies and occult blood tests (FITS), have their own sets of disadvantages. Colonoscopies, although accurate, involve an unpleasant procedure and lengthy preparation. Occult blood tests are more accepted but only provide indirect evidence of disease, often in later stages.

To address these challenges, Mainz Biomed (NASDAQ: MYNZ), a molecular genetics diagnostic company specializing in early cancer detection, has developed ColoAlert. This flagship product offers advanced screening that detects both bleeding and non-bleeding tumors through tumor DNA analysis, which the company claims provides better early detection than traditional fecal occult blood tests. Early detection is crucial as almost all colorectal cancers develop from polyps over time, increasing the risk of them becoming cancerous.

ColoAlert analyzes stool samples for four tumor markers associated with colorectal cancer: KRAS-mutation, BRAF-mutation, total amount of human DNA, and occult blood. By detecting 85% of colorectal cancer cases, often in the very early stages, ColoAlert stands out among competing at-home screenings.

The market opportunity for ColoAlert is significant. Currently, 37 million people in the U.S. are screened for rectal cancer yearly, a figure that could rise to 52 million within a decade as the population ages. The U.S. population over 50 is expected to grow from 112 million to 157 million over the next ten years, with about 40% of individuals aged 50 to 75 never having been screened. The FDA recommends starting screening at age 45, to be conducted every three years, further expanding the potential market. Mainz estimates a $4 billion market opportunity in the U.S. and $6 billion in Europe.

ColoAlert's accuracy has been validated in a multicentric study of 566 patients, where it outperformed other non-invasive screening methods with a sensitivity of 85% and specificity of 92%. This high accuracy rate is likely to drive adoption and help Mainz Biomed achieve its goals. Researchers from the study noted, “Combined DNA stool assay represents a reliable assay for detecting colorectal cancer, sufficient to be recommended as a supplement to colonoscopy screening.”

Ease of use is another factor that makes ColoAlert appealing. The test can be completed in five minutes, with patients receiving a kit by mail containing instructions, a stool collector, and a shipping label to return the sample to a local lab. Results are received within a few days. Unlike its rival ColoGuard, ColoAlert requires very small samples, contributing to a 98% patient satisfaction rate.

Colorectal cancer is the third most commonly diagnosed cancer and a leading cause of cancer death globally. Early detection can make a significant difference, and Mainz Biomed hopes that ColoAlert will encourage more people to get screened, thereby reducing the incidence of colorectal and other gastrointestinal cancers.

To learn more about ColoAlert and the science behind it, click here.