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A Closer Look at FIT Tests – A Primer on the Various Options for Colorectal Cancer Screening

As we confront the sobering statistics and growing impact of colorectal cancer, it's clear that more education about the various options for testing is needed to increase screening rates across the U.S.

Results from a new JAMA Network study support the large-scale use of FIT tests. The findings show that those who complete one or more fecal immunochemical test (FIT) screenings are associated with a 33% lower risk of death from colorectal cancer. 

The news is promising, given colorectal cancer (CRC) is now the leading cause of cancer deaths in men under the age of 50 and second for women under 50. However, work remains to be done. 

Despite its proven effectiveness, FIT testing is still underutilized.  Lack of awareness is a key barrier.  As we confront the sobering statistics and growing impact of colorectal cancer, it’s clear that more education about the various options for CRC testing is needed to increase screening rates across the U.S.

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Unraveling the complexity of screening options

The reality is that many people still don’t even know FIT tests exist –  let alone how they compare to other screening methods, such as stool-based DNA and emerging RNA and blood tests. The growing number of stool-based tests now available over-the-counter in pharmacies and online adds to the confusion. 

Indeed, over the past few years, the number of at-home stool tests has exploded. Consumers need guidance to help determine which one is best for them, when to take the test, and what to do with the results. 

Pharmacists are in an ideal position to provide this guidance and education. Leveraging their expertise and accessibility, pharmacists can significantly enhance public awareness and utilization of FIT tests. They can provide insights into the convenience, costs, and insurance coverage of different tests, helping consumers make more informed decisions. 

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But with the growing number of brands, each with different features and benefits, it can take a lot of work for pharmacists (and all of us) to keep pace with the specifics of every test.  Here is a basic overview to help clinicians better understand the evolving maze of CRC testing options. 

  • Colonoscopies: Most people know about colonoscopies. Colonoscopies remain the gold-standard screening test. They’re the only method that allows gastroenterologists to detect and remove potentially precancerous colon polyps. However, the procedure is invasive and time-consuming. It requires bowel preparation days in advance, and patients are often sedated during the procedure. In most cases, colonoscopies are only covered by insurance for patients over the age of 45. They are routinely done once every 5 to 10 years depending on family health history and previous screening results. 
  • Multitarget stool DNA (Cologuard):  Multitarget stool DNA (mt-sRNA) tests, such as the heavily advertised ColoGuard, can help patients avoid some downsides of colonoscopies. These tests require people to collect a stool sample and mail it to a lab, where it can be examined for specific high-risk gene mutations indicating the presence of potential precancerous polyps and blood. Unlike colonoscopies, mt-sRNA tests don’t require special preparation and can be done at home. However, they do require a prescription and cost around $500-600, some of which may be covered by insurance depending on the plan. Typically, patients repeat these tests every three years. 
  • Multitarget stool RNA (ColoSense): In May, the FDA approved Geneoscopy’s mt-sRNA test, which is said to be the first to utilize RNA biomarkers to detect the presence of colon cancer. The prescription-only test also involves collecting a stool sample at home and sending it to a lab for analysis. However, it is meant for use in adults at least 45 years of age who are at average risk of developing CRC. The company is currently in discussions with payors and is expected to be commercially available in late 2024 or early 2025. 
  • Blood tests (Guardant Health Shield): CRC screening options recently expanded to include a blood test known as a cfDNA test, which makes screening as simple as giving some blood. The new test detects DNA fragments shed by tumor cells and precancerous growths. It was recently approved by the FDA and is not yet covered by insurance, but is available for sale for a reported $895. Guardant recommends testing with its blood test every three years.
  • FIT tests (EZ Detect, Everlywell, ColoTest): FIT stands for fecal immunochemical test, which screens for blood in stool – a key warning sign for CRC. Experts widely agree that FIT tests may be the best option for CRC screening for various reasons, mainly because they are the ones most people will actually complete. It is undeniably the cheapest option and is available to people of all ages without a prescription. A downside of some of the older, legacy FIT tests is that they may only be effective with certain dietary restrictions. Newer FIT tests have no restrictions and deliver immediate results in the home. FIT tests are recommended for use annually. While FIT tests can offer a convenience that other CRC screening options can’t, they are only meant to be used as a starting point. If the results are abnormal, all stool-based tests must be paired with a colonoscopy to be effective. (Disclosure: ColoTest is a product of the author’s company.)

With colorectal cancer remaining a leading cause of cancer deaths, particularly among younger populations, increasing awareness and education about these various tests is essential.  Pharmacists and others across the care continuum will be pivotal in guiding patients through their choices, ensuring they are well informed and equipped to make decisions that best suit their needs. 

As we navigate the evolving landscape, it’s crucial to balance effectiveness with accessibility. While colonoscopies remain a valuable tool in detection, the barriers to access and discomfort associated with the procedure are undeniable.  By expanding the use of more affordable and accessible screening methods like FIT tests, we can help turn the tide against colorectal cancer and ensure a brighter, healthier future for all.

Photo: sorbetto, Getty Images

Jeffrey Reese is the president of Cleveland-based Reese Pharmaceutical.

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