Background: Screening reduces colorectal cancer (CRC) mortality, but many persons remain unscreened. Screening with a blood test could improve screening rates. We estimated the comparative effectiveness and cost-effectiveness of CRC screening with emerging biomarkers, illustrated by a methylated Septin 9 DNA plasma assay (mSEPT9), vs. established strategies. Methods: We conducted a cost-utility analysis using a validated decision analytic model comparing mSEPT9, fecal occult blood testing (FOBT), fecal immunochemical testing (FIT), sigmoidoscopy and colonoscopy, projecting benefits and costs over a lifetime. Results: In the base case, mSEPT9 decreased CRC incidence by 35-41% and CRC mortality by 53-61% at costs of $8,400-$11,500/quality-adjusted life year gained vs. no screening. All established screening strategies were more effective than mSEPT9. FIT was cost-saving, dominated mSEPT9, and was preferred among all the alternatives. Screening uptake and longitudinal adherence rates over time strongly influenced the comparisons between strategies. At the population level, mSEPT9 yielded incremental benefit at acceptable costs when it increased the fraction of the population screened more than it was substituted for other strategies. Conclusions: mSEPT9 appears to be effective and cost-effective compared with no screening. In order to be cost-effective compared with established strategies, mSEPT9 or blood-based biomarkers with similar test performance characteristics would need to achieve substantially higher uptake and adherence rates than the alternatives. It remains to be proven whether CRC screening with a blood test can improve screening uptake or long-term adherence compared with established strategies. Impact: Our study offer insights into the potential role of CRC screening with blood-based biomarkers.
View details for DOI 10.1158/1055-9965.EPI-13-0204
View details for Web of Science ID 000324674500010
View details for PubMedID 23796793