FDA to watch over genetic testing

The United States Food and Drug Administration has notified 5 major genetic testing companies of their intent to regulate genetic tests sold to the public.

The FDA has stated that several of these companies have provided no clinical validity concerning their products and must comply with federal regulations concerning medical devices available to the public. Concerned with inaccurate information influencing personal decisions in an irresponsible fashion the FDA has made it clear that these companies will have to meet their standards before making their products widely available.

The companies notified were NaviGenics, 23andMe, Illumina, Knome, and deCode genetics. A similar letter was issued to Pathway earlier this year when an announcement was made concerning their product being distributed through Walgreen’s drugstores. Most companies indicate an effort to be involved in a positive fashion with the FDA with NaviGenics going so far as saying they have been approved by regulators in every state and welcome federal regulation as the next step.

The intent of personal genetic testing is to disclose certain predispositions based upon one’s genes and better identify patterns of behavior to increase one’s health based on these findings. Concerns have abounded regarding these tests being somewhat inaccurate or providing only partial information. Regulators are concerned about actions taken in response to these tests without medical consultation such as altering prescriptions or forsaking treatment for certain conditions.

23andMe also disclosed that a lab of theirs may have caused up to 96 customers to receive genetic information that was not their own due to a misstep. While efforts are reportedly being taken to ensure that was a one time occurrence it doesn’t help dissolve the heightened concerns of the FDA.