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FDA warns three US firms over direct-to-consumer genetic testing

16 November 2015
Appeared in BioNews 828

The US Food and Drug Administration (FDA) has sent warning letters to three gene-testing companies over the marketing and selling of what it claims are direct-to-consumer (DTC) gene-testing products without its approval.

The FDA said it was concerned about the potential public health consequences of test results.

Mr Eric Pahon, press officer at the FDA said that while the agency acknowledged that consumers are interested in information about genetic risks for disease, there were grounds for concern regarding the DTC tests.

'[The FDA] believes that certain types of tests are being appropriately offered through the DTC model, but others may need to demonstrate that they are safe and effective and that appropriate controls are in place to mitigate risks,' Pahon said.

The FDA said that the tests in question meet the criteria of a medical device and therefore require approval. Letters were sent to DNA4Life, DNA-cardioCheck and Interleukin Genetics and stated that the FDA does not hold an approval for the tests in question. The companies must either provide evidence that approval has been given, or explain why the tests should not be considered products requiring approval.

Both DNA4Life and Interleukin Genetics have said that they do not believe they needed FDA approval to sell the test. DNA4Life has also argued that its test is 'physician-integrated', meaning that patients are required to share test results with a physician. There is some concern, however, over how patients will interpret test results to make decisions about the drugs they are taking, reports Reuters.

The FDA has previously warned several companies about the marketing of DTC gene tests. Among these is the gene testing company 23andMe, which discontinued the marketing of its health-related DTC genetic testing service in 2013 after being ordered to do so by the FDA (see BioNews 733).

The company has recently relaunched revised tests with FDA approval that will show carrier data for 36 genetic diseases, as well as predisposition tests for trait and wellness characteristics (see BioNews 825).

However, previous reports offering indications of adverse drug reactions and risk for common disorders with a genetic component were discontinued due to lack of approval by the FDA. The agency said that that the test results had low reliability, that test results could lead to self-management of drugs and that the rates of false positives and false negatives were unknown.

FDA Sends DNA4Life Untitled Letter Regarding Pharmacogenetic Report Product
genomeweb |  9 November 2015
FDA sends letter to DNA4Life over consumer gene tests
Reuters |  11 November 2015
FDA Sends Warning To Three Companies Over Direct-To-Consumer Gene Tests
Tech Times |  11 November 2015
FDA Warns Three Companies Over DTC Genetic Tests
Regulatory Affairs Professional Society |  9 November 2015
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