The Role of ColoAlert® in future healthcare

Screening with colonoscopy is a highly sensitive diagnostic procedure without falsepositives and has been widely considered as the gold-standard in CRC screening. However, in practice colonoscopy screening is faced with poor patient acceptance and uptake due to its invasive nature and associated risks, rarely exceeding 20% participation rates. The noninvasive FIT stool test in comparison reaches a higher acceptance level of 73% and more [10] , however misses up to 37% of all affected patients and hence fails to meet the minimum recommended specificity goals of 90% [11] . This calls for the development of more sensitive stool tests, especially for improving the detection rates in the early CRC stages that allow for 5-year-survival-rates of 85 % and more.

Stool tumour DNA testing can thus be considered as the future of CRC screening, offering a superior combination of sensitivity and specificity (Youden Index) than the FIT – while even enhancing patient acceptance and uptake. In conclusion, when factoring in specificity and/or price –

is a promising screening tool for European healthcare systems, delivering very good performance characteristics and a leading patient compliance at a price point where health systems should be able to easily amortize the initial investments. The overall evidence for stool DNA testing is sufficient to start public screening, at least in a pilot project. A larger evaluation of its practical benefits and the health-economic impact seems commanded.

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