Epigenomics reports micro-simulation model results on Epi proColon
Epigenomics reported on micro-simulation model results indicating that Epi proColon, a colorectal cancer screening test approved for patients who are unwilling or unable to be screened by the United States Preventive Services Task Force recommended methods, provides clinically meaningful reductions in the incidence and mortality of CRC comparable to those of USPSTF currently recommended 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. 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 trials and those of the National Cancer Institute's Cancer Intervention and Surveillance Modeling Network models. 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: adherence fixed at 100%; adherence based on published rates. Sensitivity analyses based on varying initial and resulting overall adherence rates were also conducted. Key findings from the study include: Assuming an adherence rate of 100%: FIT-DNA, FIT, HS-gFOBT, and SEPT9 averted 42-45 CRC cases and 25-26 CRC deaths; COL averted 46 cases and 26 deaths; CTC 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, SEPT9, CTC, and COL strategies; 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 COL every ten years or SEPT9 every year 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.