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FDA questions five US companies about unapproved genetic testing

28 June 2010
Appeared in BioNews 564

The Food and Drug Administration (FDA) has told five US companies that the genetic tests they sell directly to consumers are unapproved.

In a letter to one of the personal genetics companies, Alberto Gutierrez, in charge of diagnostic test regulation at the FDA, said that because the genetic tests are 'intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease', or are 'intended to affect the structure or function of the body', they are considered medical devices.

Medical devices are required to receive regulatory approval before they can be marketed. Gutierrez writes that pre-market review allows for an independent assessment of the test's ability to generate reliable results, upon which consumers can base good healthcare decisions.

The decision of the FDA to only now question the regulation of these devices has emerged as companies have modified their claims - from determining paternity or ancestry, to claims that are more medical and higher risk. Gutierrez told USA Today that the ones they're worried about 'are those that say something about drug metabolism or those that define risks for major diseases'. He specified, 'definitely all the cancer ones are ones that we think are high-risk'.

In response, 23andMe issued a statement disagreeing with the FDA, saying they believed their consumers had the right to access as much information about their genes and bodies as they choose, but also stated they were open to discussions on ways to regulate the personal genetics industry.

Gutierrez stated that they did not want to deny people information, but simply make sure people were given correct information.

Daniel Vohause, an independent lawyer specialising in genetic testing regulation, told The New York Times that no-one had a clear understanding of where the FDA were drawing the line at this point - the FDA has not removed the test from the market, simply initiated investigation as to an appropriate regulatory framework for approval. Vohause said the FDA was 'trying to keep up with a commercial space that is moving way faster than they are capable of'.

F.D.A. Faults Companies on Unapproved Genetic Tests
NY Times |  11 June 2010
FDA groups genetic tests with medical devices, requiring approval
USA Today |  15 June 2010
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