Ethics and clinical utility of direct-to-consumer genetic tests

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...

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...

The Ethics of Direct-to-consumer Testing

Clinical validity and clinical utility of genetic tests.

In considering the appropriate use of new genetic tests, clinicians and health care policymakers must consider the accuracy with which a test identifies a patient's clinical status (clinical validity) and the risks and benefits resulting from test use (clinical utility). Genetic tests in current use vary in accuracy and potential to improve health outcomes, and these test properties may be infl...

Limitations of direct-to-consumer advertising for clinical genetic testing.

Although direct-to-consumer (DTC) advertisements for pharmaceuticals have been appearing in the mass media for 20 years, DTC advertisements for genetic testing have only recently appeared. Advertisements for genetic testing can provide both consumers and physicians with information about test availability in an expanding market. However, 3 factors limit the value and appropriateness of advertis...