Q&A: Patients who refuse FIT, colonoscopy prefer blood test for CRC screening
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A study published in the Journal of the National Cancer Institute concludes that Epi proColon is the test of choice for individuals not willing to participate in fecal immunochemical tests or colonoscopy screening.
Healio Gastroenterology spoke with Greg Hamilton, CEO of Epigenomics AG, to discuss the study results and next steps.
Healio: What was the purpose and design of the study?
Hamilton: The purpose was to determine which of the available alternatives to FIT and colonoscopy is the most promising from a cost-effectiveness perspective.
Investigators used the cancer intervention and surveillance modeling network-microsimulation screening analysis (CISNET-MISCAN) colon model to evaluate the cost effectiveness of the following methods:
- CT Colonography every 5 or 10 years;
- Multi-targeted stool DNA (mtSNDA; Cologuard) every 1 or 3 years;
- Methylated Sept9 DNA (mSEPT9; epi proColon) every 1 or 2 years; and
- PillCam every 5 or 10 years.
The MISCAN model was developed by the Department of Public Health within the Erasmus University Medical Center, Rotterdam, the Netherlands. It is part of the U.S. National Cancer Institute’s CISNET and has been used to inform colon cancer screening recommendations such as the United States Preventative Services Task Force and the American Cancer Society.
Healio: What were the results of the study?
Hamilton: Study results suggest that for individuals not willing to participate in FIT or colonoscopy screening, mSEPT9 is the test of choice if the high colonoscopy referral rate is acceptable to them.
Additionally, investigators found annual mSEPT9 testing was clinically more effective (reduction in incidence and mortality of colon cancer) than mtSNDA every three years and annual FIT testing.
Healio: What was the take-home message?
Hamilton: mSEPT9 is the “test of choice” for patients who are unwilling to participate in FIT or colonoscopy screening based on its clinical performance and cost effectiveness.
Healio: What was the conclusion?
Healio: mSEPT9 is an FDA approved colon cancer screening test that is highly effective and cost efficient. Medicare is currently evaluating coverage of mSEPT9 and their preliminary decision will be released in approximately 2 weeks. Based on the significant amount of evidence including this recent Journal of the National Cancer Institute publication, we believe CMS will issue a positive coverage decision for mSEPT9. This means that by then end of November, Medicare patients who don’t participate in FIT or colonoscopy screening will have the opportunity to take the only FDA-approved blood test for CRC screening, epi proColon (assuming a positive coverage decision). Considering there are millions of unscreened Medicare patients, this new technology has the potential to save hundreds of thousands of lives.
Healio: What is the next step in research?
Hamilton: As part of epi proColon’s FDA premarket approval, the company is conducting a “post approval study” (PAS). PAS studies are required for all premarket approval application approved products. This is a longitudinal study that will verify the long-term performance of the test. The study is expected to be completed within the next 2 to 3 years.
Editor's Note: On August 17, 2020, Healio Gastroenterology updated the lead and headline to clarify the study results.
Perspective
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Carol A. Burke, MD
Colorectal cancer, a leading cause of cancer deaths in American men and women, can be diminished in individuals who undergo colorectal cancer screening. There are a variety of available methods for colorectal cancer screening, including colonoscopy, stool and blood tests, and imaging studies like CT colonography (CTC) and capsule colonoscopy. Unfortunately, colorectal cancer screening is underutilized in eligible individuals in the United States (US). Understanding which screening method saves the most lives and with less cost to society is important. This study used mathematical modeling to inform us which test beyond the most common colorectal cancer screening methods used in the US, including colonoscopy and fecal immunochemical (FIT) stool testing, was the most cost effective and increased the quality of life years gained, which are important considerations for population health care. One downside is the model used 100% adherence to the screening strategy, including follow-up of abnormal findings. We know that up to 25% of individuals that undergo a screening method short of colonoscopy do not return for follow-up of their positive screening test. Therefore, the benefits assigned in the study for non-colonoscopy screening methods may be overestimated.
The most important finding when comparing all the screening strategies was that both annual FIT and colonoscopy every 10 years were the dominant strategies and colonoscopy saved most lives. The next most cost-effective strategy was annual mSEPT9, compared to the multi-target stool test, CTC and capsule colonoscopy. However, with a mSEPT9 sensitivity and specificity to detect colon cancer at only 68% and 79%, it may be a hard sell to patients.
It’s important that we have alternative colorectal cancer screening options for patients who refuse colonoscopy or FIT testing, but we need to offer tests that are accurate and ensure patients understand if the alternative test is positive, a colonoscopy is required.
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