Direct-to-consumer genetic tests: beyond medical regulation?

The regulation of direct-to-consumer genetic tests.

The past year has been marked by the emergence of several companies, such as 23andMe, deCODEME, Navigenics and Knome, offering tests using genome-wide technology direct to consumers over the internet. On the basis of the published research findings of GWAS and other studies, these companies will calculate an individual's risk to a number of common diseases, without the necessity of going throug...

FDA to regulate direct-to-consumer genetic tests.

began, genetic tests were available for about 100 diseases — most of them caused by just one faulty gene, such as the mutations that cause Tay-Sachs and cystic fi brosis. As genomic technologies matured and sequencing became less costly, companies began developing tests for a wider range of complex, multigenic, common diseases. These were initially offered by laboratories used by physicians, bu...

Direct-to-Consumer Marketing of Predictive Medical Genetic Tests: Assessment of Current Practices and Policy Recommendations

This research reviews the current state of affairs in the fast-growing area of direct-to-consumer marketing of genetic tests. The authors identify the unique nature of genetic tests and the ensuing consumer vulnerability. They also present a comprehensive examination of the current legal environment and an empirical analysis of genetic testing companies’ online marketing practices. On the basis...

Regulating direct-to-consumer genetic testing: protecting the consumer without quashing a medical revolution.

Awareness of Direct-to-Consumer Genetic Tests and Use of Genetic Tests Among Puerto Rican Adults, 2009

INTRODUCTION Genetic testing remains low among racial/ethnic minority populations in the United States. We aimed to determine the prevalence and correlates of awareness of direct-to-consumer (DTC) genetic tests and the prevalence of genetic test use in a population-based sample of adults in Puerto Rico. METHODS We analyzed data from adults aged 18 years or older who completed information on g...