OTC Colon Cancer Screening Test Now Available in Pharmacies Across US

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Reese Pharmaceutical’s ColoTest has a suggested retail price of $19.99 and will also be sold on major retail shelves later this spring.

Reese Pharmaceutical has launched a new at-home Fecal Immunochemical Test (FIT) that helps identify hidden blood in stool to support the early detection of colon cancer or gastrointestinal disorders like colitis, diverticulitis, and polyps. ColoTest is available over-the-counter and has a suggested retail price of $19.99, the company announced in a press release.1

women holding colon model / ryanking999 - stock.adobe.com

women holding colon model / ryanking999 - stock.adobe.com

ColoTest received FDA clearance in September 2023. The product provides individuals an easy-to-use, affordable test that can be performed at home. Users place a sheet of paper provided in the kit over the toilet to collect the sample. A brush is used to collect a portion of the sample in a tube, then a sampler is added to produce a reaction. Those who receive a positive result are advised to contact their doctor for further testing.

Key Takeaways

  • Reese Pharmaceutical has introduced ColoTest, a new at-home Fecal Immunochemical Test (FIT) designed for the early detection of colon cancer or gastrointestinal disorders like colitis, diverticulitis, and polyps.
  • ColoTest is an over-the-counter product with a suggested retail price of $19.99. It received FDA clearance in September 2023, providing individuals with an accessible and non-invasive screening option for colorectal health.
  • With colon cancer rates on the rise, early detection is crucial. ColoTest aims to provide a convenient and proactive screening option, contributing to the effort to prevent colorectal cancer-related deaths.

“We're proud to introduce ColoTest to help meet this challenge by delivering a convenient, affordable, non-invasive screening option that enables people to identify invisible blood in stool, a key warning sign for colorectal cancer, diverticulitis, gastrointestinal disorders, colitis and polyps,” Jeffrey Reese, president of Reese Pharmaceutical, said in a release.1 “This test is performed in the comfort of your own home with results at home as soon as 1 minute.”

Although cancer deaths have been declining in the United States since 1991, colorectal cancer incidence rates increased 1% to 2% annually from 2015 through 2019 in adults 55 years of age or younger. The condition now represents the leading cause of cancer deaths in men and the second leading cause among women.2

In May 2021, the US Preventive Services Task Force (USPSTF) updated their guidance on colonoscopies in response to the rising rates of colorectal cancer among younger adults.3 The independent panel of experts lowered the recommended age to start screening from 50 to 45 based on statistical modeling that suggested starting at age 45 may increase life years gained.

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“Far too many people in the US are not receiving this lifesaving preventive service,” Michael Barry, MD, vice chair of the USPSTF, said in a release at the time of the update.4 “We hope that this new recommendation to screen people ages 45 to 49, coupled with our long-standing recommendation to screen people 50 to 75, will prevent more people from dying from colorectal cancer.”

Colonoscopies remain the gold standard of colorectal cancer screening, although stool sample tests are also recommended by the FDA. However, some individuals do not become eligible for the procedure until they reach age 45 and others may not have proper insurance coverage or feel comfortable with the test. A blood test is also approved by the federal agency, but is only recommended when a colonoscopy or stool sample test cannot be performed.5

In 2021, 71.8% of adults aged 50 to 75 received a colorectal cancer screening and the USPSTF set a goal of reaching 74.4% by 2030 as part of their Healthy People Target.

"90% of colon cancer-related deaths are thought to be preventable if caught early, and yet more than 29 million Americans are not screening for it,” Reese said in a release.1 “With colon cancer rates on the rise, it is more important than ever for people to be proactive.”

Reese Pharmaceutical, which has been serving the industry for over 100 years with a suite of products across cough and cold, digestive care, family planning, feminine health, and first aid, said ColoTest will also be available in major retail stores across the country later this spring.

READ MORE: Oncology Resource Center

References
1. Reese Pharmaceutical Launches New At-Home Colon Cancer Screening Test. News Release. Reese Pharmaceutical. February 27, 2024. Accessed February 27, 2024. https://www.prnewswire.com/news-releases/reese-pharmaceutical-launches-new-at-home-colon-cancer-screening-test-302070648.html
2. Siegel RL , Giaquinto AN , Jemal A. Cancer statistics, 2024. CA Cancer J Clin. 2024; 74(1): 12-49. doi:10.3322/caac.21820
3. Colorectal cancer screening. Report. NIH. August 2023. Accessed February 27, 2024. https://progressreport.cancer.gov/detection/colorectal_cancer
4. U.S. Preventive Services Task Force Issues Final Recommendation on Screening for Colorectal Cancer. News Release. USPSTF. May 18, 2021. Accessed February 27, 2024. https://www.uspreventiveservicestaskforce.org/uspstf/news
5. Colorectal Cancer: What You Should Know About Screening. Report. FDA. March 3, 2023. Accessed February 27, 2024. https://www.fda.gov/consumers/consumer-updates/colorectal-cancer-what-you-should-know-about-screening
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