Health and Medical News and Resources

General interest items edited by Janice Flahiff

Risks of Presymptomatic Direct-to-Consumer Genetic Testing

At home genetic testing kits have been available online for some time.  However geneticists have long warned about the dangers of consumers self testing without clinical guidance in self testing and self diagnosing.

The Food and Drug Administration has sent warning letters to at least 20 companies planning on selling these kits as over the counter items. The letters state  direct-to-c0nsumer  genetic testing may require FDA approval. At least one company has since postponed selling the kits in their stores.

Excerpts from a recent New England Journal of Medicine perspective on home genetic tests

When population screening for medical conditions is independent of any defined individual risk, the screening program should adhere to established principles in order to avoid undue harm and expense: there must be a suitable and acceptable test addressing an important health problem that has a recognizable latent or early symptomatic state, a well-understood natural history, and an accepted and available treatment or intervention.4,5 Most genetic screening currently cannot meet such expectations. More important, DTC genetic screening may place a substantial burden on the health care system without providing demonstrable benefit.


The potential harms of DTC genetic testing include the loss of protections for patients offered by established health care delivery systems (e.g., doctor–patient confidentiality and beneficence), invalid analytic or clinical results from medical devices, and population screening without consensus on interpretation and follow-up. These risks must be balanced against the potential benefits of innovation. The government’s role in this arena should include both regulation and the funding of collaborative research that enables the optimal use of genetic information.

August 24, 2010 - Posted by | Health News Items | ,

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