Direct-to-Consumer Genetic Testing: A History of Business Models

Background: Due to the intervention of the American Food and Drug Administration (FDA) in the previously unregulated market of direct-to-consumer (DTC) genetic testing in 2013, providers were forced to adapt certain business practices to the new requirements. This has brought changes in the business models, which will be researched further.
Objective: With this thesis we look at the changes in the business models of DTC genetic testing providers in the past.
Methods: For this purpose, the first systematically developed taxonomy by Thiebes et. al. (2020) is used, which is a snapshot of the year 2018, but does not consider the past. The referenced taxonomy is applied to the years 2008/2009 as well as 2013/2014 to investigate the temporal course of the changes. 55 services are selected and examined in the different time periods.
Results: Our paper shows that regulatory measures can have an impact on the business models of DTC genetic test providers. To understand the extent of the changes, further research on the background and interrelationships of the DTC genetic test market is required. This will allow us to better assess the response of DTC genetic test providers to warnings and bans by regulators. ... mehrIn turn, this will allow legislators to be more specific about the alignment of competitive conditions and consumer protection.
Conclusion: The changes in the business models between the periods 2013/2014 (after the FDA intervention) and 2018 are particularly evident.