Proposed regulatory framework for direct-to-consumer genetic testing: diagnostics vs genetic screening.

Direct-to-consumer genetic testing: driving choice?

Direct-to-consumer genetic testing (DTCGT), which includes both the advertising and offer of genetic tests directly to the public [1], existed for many years before the, now famous, companies such as deCODE and 23andme made their appearance on the market [2]. However, the sharp increase in companies offering DTC-GT over the last 3 years has sparked much regulatory and ethical debate [3–5]. The ...

The current landscape for direct-to-consumer genetic testing: legal, ethical, and policy issues.

This review surveys the developing market for direct-to-consumer (DTC) genetic tests and examines the range of companies and tests available, the regulatory landscape, the concerns raised about DTC testing, and the calls for enhanced oversight. We provide a comparative overview of the situation, particularly in the United States and Europe, by exploring the regulatory frameworks for medical dev...

Direct-to-Consumer Genetic Testing: A Comprehensive View

Direct-to-consumer (DTC) genetic testing refers to testing sold directly to consumers via the Internet, television, or other marketing venues without involving health care professionals. As the recent Supreme Court ruling eliminated the patentability of human genes, this rapidly evolving segment in the laboratory testing industry is starting to attract increasing scrutiny by government, scienti...

Direct-to-consumer genetic testing: reliable or risky?

In recent years there has been a dramatic increase in the discovery of information related to the genetic risk of disease, as well as in the technical ability to accurately measure an individual’s genotype. These advances underlie the promise of personalized medicine, in which a patient’s genotype informs the medical care they receive. Private companies are attempting to capitalize on these adv...

Direct-to-consumer marketing for genetic testing.