Γενετικές εξετάσεις απευθείας στους καταναλωτές (Direct to consumer genetic tests): μελέτη της ικανοποίησης των χρηστών

Abstract

This thesis deals with the study of an aspect set related to genetic tests that are provided directly to consumers without the involvement of a specialist, as well as the effect of listed factors on user satisfaction. Firstly, there is a brief introduction that outlines the differences between genetic tests and those that are offered directly to the consumer, but also the impact of one form on another. Then, we analyze the concepts and procedures, which are the basis for the rest of the analysis, such as: the concept of medical device, the market notification procedures 510 (k), the Premarket approval (PMA) and the request for De Novo classification. At the same time, there is a historical review with emphasis on the key points from their first appearance of these genetic tests until today. In addition, there is a very extensive presentation of current legislation in both the European Union and the United States of America, highlighting the gaps for which the need for structural change and intervention is imperative. We continue with marketing content and the dominant business models adopted by the relevant companies, as well as the main differences in the techniques of the dominant “market players” that justifies the risk stratification and the integration of users at different levels. The next chapter of this study presents the ranking of examination based on their demand, while pointing out key factors shaping their price which showed an excessively downward trend. \nThe research study is completed with the formulation of the research problem, the research methodology, the statistical analysis of data using the model of ordinal logistic regression, the analytical recording and interpretation of the results, ending up with conclusions coming from the extensive previous analysis. All of the above, combined with the emerging conclusions and posted user reviews, help the reader to deepen in the existing context of these tests, as well as to set future research goals.