24-Feb-15 1:00 PM  CST

Direct to the Consumer Genetic Testing May Soon Be Available to the Public

Last week the federal Food and Drug Administration announced that they would permit a California company to sell a minimal number of DNA testing kits direct to the public. This unprecedented move by the FDA has some calling it a move forward in combating or at least predicting the incident of some genetic diseases.

23andMe, a privately based genomics and biotechnology company, has been given the green light from the FDA to sell a small number of a DNA kit to test for Bloom syndrome, a genetic disease that typically leads to small stature in children, but can may also lead to much more serious disease states such as cancer. Some healthcare professionals believe genetic testing, which can help predict debilitating genetic diseases such as Cystic Fibrosis, Tay-Sachs Disease, and Sickle Cell Anemia, is invaluable tool in fighting genetic diseases. Currently, genetic testing is only available when ordered from a physician.

This is not the first time genetic testing kits have been marketed by 23andMe. In November 2013 23andMe marketed genetic testing kits to the public, but was warned by the FDA to stop selling the kits for fear that drug responses may cause patients to self-medicate. For example, patients taking warfarin, an anticoagulant that requires close monitoring, may have a false genotype response that may cause patients to use the drug improperly. Many in the healthcare industry were surprised by FDA’s decision to be so indulgent in allowing 23andMe to sell its genetic testing kits to the public.

This most recent decision by the FDA, which stated no preliminary review, was needed prior to allowing genetic testing kits to be sold to the public, clears the way for other genetic kits to be marketed to the public. The FDA’s change of heart from 2013 is seen as a positive move in the right direction by many, but one that must also be taken with caution





Burton, T. and Gormly, B. (2015) “FDA signals easier rule on genetic tests”, Wall Street Journal, http://www.wsj.com/articles/fda-signals-easier-rule-on-genetic-tests-1424468927, retrieved 21.February, 2015


WebMD (2015), “Public access to genetic test made easier by the FDA”, http://www.webmd.com/news/20150220/fda-genetic-tests, retrieved 21.February 2015

For additional information on this article, please contact:
Kelley Simmons
Source: Sandy Andrews  

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