FDA cracking down on commercial genetic tests


The US Food and Drug Administration (FDA) has cracked down on five manufacturers of genetic tests, sending them letters saying they must gain federal approval before marketing their tests. The letters, posted online last week, are a sign that the FDA is taking a tough line with companies which market products to predict inheritable diseases.

These products are medical devices, argues the FDA, and must therefore be approved as effective and safe. The letters deal with technologies from: 23andMe Inc., Illumina, Navigenics, Knome Inc., and Decode Genetics.

23andMe Inc, Decode Genetics and Illumina market tests that screen patients for their chances of developing health conditions or for their response to drugs. According to the FDA, none of them have submitted these tests for approval. 

Knome Inc. and Navigenics make top-notch genetic testing and software equipment for companies to analyse DNA samples. FDA regulations state that those technologies must also be reviewed as medical devices.

Interest in genetic testing, particularly for inheritable genetic defects and diseases, has grown rapidly in recent years. Joan Scott, director of the Genetics & Public Policy Center at John Hopkins University told Newsweek: "People have a great deal of optimism and interest in having information. It could motivate health changes and give them a sense of control. And they could follow up on it and participate in research." ~ MSNBC, June 11,:Newsweek, Jun 9




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