In September 2023, the FDA cleared an at-home Fecal Immunochemical Test (FIT) from Reese Pharmaceutical. ColoTest, which is available over-the-counter, helps identify hidden blood in stool to support the early detection of colon cancer or gastrointestinal disorders like colitis, diverticulitis, and polyps.
Reese announced in February that the new test was available in pharmacies across the country for a suggested retail price of $19.99. ColoTest also recently became available on Amazon and is soon set to be on shelves in Walmart. Drug Topics sat down with Jeffrey Reese, president at Reese Pharmaceutical, to talk about the importance of colorectal cancer screening, what sets ColoTest apart from other at-home tests, and how it can help reach underserved communities.
Key Takeaways
- ColoTest provides a convenient and affordable option for at-home colorectal cancer screening, aiming to address the significant impact of colorectal cancer as a leading cause of cancer-related deaths.
- ColoTest stands out from existing at-home screening options due to its simplicity, accessibility, and affordability. With no age or dietary restrictions, and results available in just one minute, ColoTest offers a user-friendly alternative to traditional screening methods.
- With availability in major retailers like Walmart and online platforms like Amazon, ColoTest aims to reach underserved communities, improving access to screening and addressing disparities in colorectal cancer detection and prevention.
Drug Topics: How important is regular colorectal cancer screening, and what role does ColoTest play in facilitating early detection?
Jeffrey Reese: Colorectal cancer is the fourth most commonly diagnosed cancer in the U.S. and the second leading cause of cancer death. In fact, the American Cancer Society estimates that more than 152,000 people in the U.S. will be diagnosed with colorectal cancer in 2024, and more than 53,000 will die from the disease. Too many lives are impacted by this cancer.
The good news is that colorectal cancer is considered preventable and highly treatable when caught early. The bad news is that more than 29 million Americans are still not screening for it. Another troubling trend is the recent report by the American Cancer Society highlighting that nearly double the number of young adults under 55 are being diagnosed with colorectal cancer compared to a decade ago.
Colonoscopy is the gold standard for colorectal cancer screening. However, for some people who may not be easily able or willing to undergo a colonoscopy, other options are available and can help address some of the existing barriers to people getting a colonoscopy. These include fecal immunochemical tests (FIT) such as ColoTest. ColoTest is an at-home colon cancer screening test that works to detect hidden blood in the stool, which can be an early warning sign for not only colorectal cancer but also diverticulitis, colitis, polyps, and other gastrointestinal disorders. People who receive a positive result should follow up with their physician and may require a colonoscopy for further evaluation.
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Drug Topics: Can you talk about the features of ColoTest that differentiate it from existing at-home diagnostic options for colon cancer screening?
Reese: Several colorectal cancer screening options are available today for patients to consider. One of the original at-home tests leverages FOBT technology. While effective, these tests can be challenging because they involve collecting multiple stool samples over several days. Diet restrictions must also be considered to ensure the test is effective. In addition, some tests require samples to be mailed to a lab for analysis.
Cologuard is another option for colorectal cancer screening. It’s a stool DNA test for people 45 and older. While there is no prep involved, the test does require a prescription, as well as lab analysis, and typically goes through insurance. Cologuard is also only recommended for use every three years.
ColoTest is one of the newest at-home screening options available, using FIT technology. With ColoTest, users not only collect the sample at home but also receive their results at home in as little as one minute. It is available over the counter at an affordable cost for anyone to purchase out of pocket; there are no age or dietary restrictions and it’s recommended for use once a year. In short, it’s a modern option that offers consumers a simpler, more private, and accessible alternative to traditional methods. We believe the convenience and privacy ColoTest delivers will encourage more people, including younger people, to undergo colorectal cancer screening, potentially leading to earlier detection and improved outcomes.
Drug Topics: How do these features contribute to its effectiveness in early detection?
Reese: The best screening test for colorectal cancer is the one that patients are willing to use.
While colonoscopies remain the gold standard for screening, unfortunately, many people forego them due to a combination of insurance limitations and fear. Without adequate insurance coverage, the cost of a colonoscopy can be a significant barrier. Fear and anxiety surrounding the procedure can also deter individuals. For some, access is an issue. They may live far from a facility or lack transportation to and from the procedure (physicians recommend patients have a ride home if they go under anesthesia).
ColoTest offers a solution to these obstacles. The test is affordable, so people can pay out of pocket for it. It’s available without a prescription and 100% non-invasive, so people can test privately in the comfort of their own homes. What’s more, the test can be purchased online through Amazon or at their local pharmacy, eliminating the need for transportation.
Put simply, ColoTest helps facilitate effective early detection of colorectal cancer by making screening more accessible, affordable, and convenient.
Drug Topics: Could you provide insights into the clinical evidence supporting ColoTest’s accuracy and reliability in detecting hidden blood in stool?
Reese: ColoTest is a fecal immunochemical test—or FIT test—that is a well-established screening method. It is recognized for its effectiveness in detecting abnormal blood in stool that may indicate the presence of colorectal cancer. ColoTest received FDA clearance through the 510(k) process. Conducted as an annual screening, ColoTest is 98.8% accurate in detecting invisible blood in stool.
Drug Topics: In light of the rising rates of colorectal cancer diagnoses, particularly among young adults, how can ColoTest address the need for increased screening accessibility and awareness?
Reese: Reese developed ColoTest with the understanding that there is not enough consumer awareness surrounding FIT technology and saw an opportunity to educate consumers about this less-expensive, more easily accessible colon cancer screening method.
The features of ColoTest may help address some of the existing barriers to colonoscopy, including for people who may have concerns or risk factors for colorectal cancer but have not yet reached the recommended age of 45 for colonoscopy outlined by screening guidelines. These patients can quickly and inexpensively access ColoTest without a prescription and receive rapid results at home that can inform and help them take control of their gastrointestinal health.
Drug Topics: How can ColoTest reach underserved communities and effectively addresses disparities in colorectal cancer screening and detection?
Reese: Approximately 90% of the population lives within 10 miles of a Walmart store. Millions of people shop on Amazon. These retailers both offer ColoTest, and are uniquely positioned to reach underserved communities across the US. In addition, an increasing number of local pharmacy teams, such as Fruth Pharmacy, are working with Reese to make ColoTest available on store shelves to ensure access to screening tests in rural communities.This improved access will likely engage more at-risk populations in screening, leading to better detection and health outcomes.
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