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By Meg Flippin, Benzinga
Colorectal cancer is a leading cause of death in America, killing 50,000 people each year. But if it's caught early, the survival rate after five years is 90%. Despite those favorable odds, only about four in 10 colorectal cancers are spotted at the early stage.
There are several reasons why more people aren’t getting screened for this devastating cancer. Some aren’t aware that regular testing can save their lives, many can’t afford it, while others don’t have access. Colonoscopies done at ten-year intervals and occult blood tests (FITS) performed annually or biannually are the two forms of screenings, but both have disadvantages. Colonoscopies, while very precise, involve an unpleasant procedure and lengthy intestinal cleansing. Occult blood tests are more widely accepted, but they can only provide indirect evidence of disease and often only in later, bleeding stages.
Advanced Screening Equals Early Detection
To be effective, cancer screening has to be simple, readily available and affordable, which is where Mainz Biomed (NASDAQ: MYNZ) comes in. The molecular genetics diagnostic company specializing in the early detection of cancer is revolutionizing the colorectal cancer testing industry with ColoAlert, its flagship product.
ColoAlert is an early detection screening that spots bleeding and non-bleeding tumors through tumor DNA analysis, offering what the company says is better early detection than fecal occult blood tests. That’s important since almost all colorectal cancers develop from polyps that grow over time. The longer the polyps are present, the higher the risk of them becoming cancerous, which is why early screening has the potential to dramatically impact treatment and prevention.
Colorectal cancer originates from the genetic mutation of intestinal cells. These are continuously excreted through the stool and can be examined for tumor DNA using modern genetic diagnostic methods. ColoAlert analyzes samples for the four tumor markers associated with cancer: KRAS-mutation, BRAF-mutation, total amount of human DNA and occult blood. That’s something competing at-home screenings can’t claim to do.
By analyzing tumor DNA, Mainz says ColoAlert detects 85% of colorectal cancer cases – often in the very early stages of the disease. That is a key differentiator, given the company says 71% of the diagnoses made are in the later stages of the disease.
Market Opportunity Is Broad
If ColoAlert proves to be game-changing in terms of getting more people to screen for colorectal cancer, it's a big opportunity for Mainz. As it stands, 37 million people in the U.S. get screened for rectal cancer each year. That could increase to 52 million per year within ten years as the population ages.
In the United States there are 112 million people over 50, which is expected to increase to 157 million in the next decade. Of the U.S. population between 50 and 75, about 40% have never been screened. While the common practice is to start the screening at 50, the Food and Drug Administration says screening should start at age 45 and be conducted every three years. If that guidance is followed, it presents an even bigger opportunity for ColoAlert. All told, Mainz pegs the U.S. opportunity at $4 billion and the European market opportunity at $6 billion.
ColoAlert is already proving to be more accurate than rivals’ at-home tests, which should drive adoption rates and help Mainz Biomed achieve its goals. A recent multicentric study of 566 patients simultaneously using the occult blood test, M2-PK test and ColoAlert, found ColoAlert, with a sensitivity of 85% and a specificity of 92%, was the most accurate test result among the non-invasive screening methods. The company plans to engage in further testing to validate the effectiveness of its screening over what’s already available in the market.
“Combined DNA stool assay represents a reliable assay for detecting colorectal cancer, sufficient to be recommended as a supplement to colonoscopy screening,” the study researchers reported.
Making It Easy
On top of being accurate, ColoAlert is easy to use, which could be a big driver of adoption. Within five minutes, the sample is collected and packaged and on the way to the lab. Patients receive a kit in the mail that includes instructions, a stool collector and a shipping label to return the kit to their local lab for testing. Patients receive the results in a few days. Unlike the rival ColoGuard, Mainz says ColoAlert requires very small samples to test, which is one of the reasons the company boasts 98% patient satisfaction.
Colorectal cancer is the third most commonly diagnosed cancer and a leading cause of cancer death globally, but it doesn’t have to be. Early detection means all the difference, yet far too many people don’t get screened each year. Mainz is hoping ColoAlert will change that, helping to lower incidents of this and other gastrointestinal cancers.
To learn more about ColoAlert and the science behind it, click here.
Featured photo by National Cancer Institute on Unsplash.
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