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Epi proColon® Screening Recommendation

The US Preventive Services Task Force, the American Cancer Society and other medical groups recommend colorectal cancer screening for men and women beginning at the age of 50. There are a number of USPSTF recommended screening tests to choose from, including Epi proColon® (mSEPT9 DNA). Epi proColon is the first and only blood test that provides an additional option for colorectal cancer screening for your patients who have received counseling and have a history of not completing screening by colonoscopy and fecal tests.

For more information, please visit the USPSTF colon cancer screening recommendation statement, available here.

Screening Methods Comparison Model

A micro-simulation model is the most effective method for comparing the clinical effectiveness among USPSTF currently recommended colorectal cancer screening methods colorectal.  The outputs include clinically meaningful reductions in the incidence and mortality.

Micro-simulation Model Methods

The micro-simulation model, developed and validated at Harvard Medical School, evaluated the impact of adherence rates, testing intervals and clinical performance of different screening strategies on CRC incidence and mortality. Results show that adherence rates and screening intervals can have a profound impact on the effectiveness of screening strategies as compared to one-time sensitivity and/or specificity. The study has been published in Cancer Medicine.1

The study was conducted using an individual-level model to simulate the natural history of CRC and enables comparison of clinical benefits, harms, and burden of alternative strategies for CRC screening. The model was validated by comparison of predicted CRC incidence and mortality, adenoma dwell times, overall dwell times and lifetime risk of developing CRC with results from two large randomized controlled trials2,3 and those of the National Cancer Institute’s Cancer Intervention and Surveillance Modeling Network (CISNET) models.4

The model used a hypothetical cohort of individuals aged 50 years or older and emulated the distribution of baseline characteristics for subjects in the landmark clinical studies. Identical cohorts were then created and assigned to different screening strategies in order to compare intervention-related differences in outcomes. The strategies and intervals were analyzed under two scenarios: 1) adherence fixed at 100%; 2) adherence based on published rates. Sensitivity analyses based on varying initial and resulting overall adherence rates were also conducted.

Clinical Effectiveness at 100% Adherence

Key findings from the study include:

  • Assuming an adherence rate of 100%:
    • FIT-DNA, FIT, HS-gFOBT, and mSEPT9 averted 42-45 CRC cases and 25-26 CRC deaths
    • Colonoscopy averted 46 cases and 26 deaths
    • CT Colonography averted 39 cases and 23 deaths and FS averted 32 cases and 19 deaths per 1,000 individuals screened
    • Estimated LYG were similar across FIT-DNA, FIT, HS-gFOBT, mSEPT9, CT Colonography, and Colonoscopy strategies

Clinical Effectiveness at Variable Adherence

  • Based on reported adherence of eligible individuals to CRC screening, per 1000 individuals screened, colonoscopy produced the best outcomes unless a non-invasive method achieves a 65% – 70% or greater adherence rate
  • Screening individuals with colonoscopy every ten years or mSEPT9 every year (assuming reported adherence rates) resulted in more favorable outcomes compared to all other strategies.
  • The impact of analytic performance on screening outcomes is heavily influenced by adherence rates and screening interval

1 Dandrea A, Ahnen DJ, Sussman DA and Najafzadeh M. Quantifying the impact of adherence to screening strategies on colorectal cancer incidence and mortality. Cancer Medicine 2019.
2 Atkin WS, Edwards R, Kralj-Hans I, et al. Once-only flexible sigmoidoscopy screening in prevention of colorectal cancer: a multicentre randomised controlled trial. The Lancet 2010; 375(9726): 1624-33.
3 Schoen RE, Pinsky PF, Weissfeld JL, et al. Colorectal-cancer incidence and mortality with screening flexible sigmoidoscopy. New England Journal of Medicine 2012; 366(25): 2345-57.
4 Joseph DA, King JB, Richards TB, Thomas CC, Richardson LC. Peer Reviewed: Use of Colorectal Cancer Screening Tests by State. Preventing chronic disease 2018; 15.