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FDA Cracks Down On Genetic Test Companies

June 13, 2010

The Food and Drug Administration is cracking down on 23andMe, as well as other companies that sell genetic tests directly to consumers.

The FDA sent letters out last week to five companies that are involved in that industry, saying their tests are medical devices that must receive regulatory approval before they can be marketed.

“Premarket review allows for an independent and unbiased assessment of a diagnostic test’s ability to generate test results that can reliably be used to support good health care decisions,” Alberto Gutierrez, who leads diagnostic test regulation at the FDA, wrote in the letters.

The letters say the companies must apply for approval or discuss with the agency why certain test claims do not require such approval.

However, the letters do not say that the test should be taken off the market until they are approved.  Gutierrez said in an interview with the New York Times that it would be unfair to remove the tests from the market because the agency had not clearly told the companies that the devices needed approval.

23andMe and two other recipients of the letters sell tests that scan a person’s DNA, looking at genetic variations that can suggest whether a person is at a higher or lower risk of getting diseases like cancer or diabetes.  23andMe is backed by Google and run by Anne Wojcicki, the wife of Google’s co-founder Sergey Brin.

Another company that received the letter, Illumina, sells DNA chips that are used by some companies to do the DNA scans.  Knome, the fifth recipient, offers consumers a complete sequence of their DNA, which can be used to learn about disease risk information.

The FDA’s letters are the latest event to take place in a long-running debate over whether and how such tests should be regulated.

Some doctors, geneticists and state regulators say the tests should be regulated because the results might be used to make medical decisions.  Others say doctors should be involved in ordering the tests and interpreting the results.

People for the new movement argue that the services merely provide information, not medical diagnosis, and that consumers have the right to the information contained in their genes. 

The companies say their tests do not require the FDA’s approval because they have been developed and are offered by a single laboratory.

Daniel Vorhaus, a lawyer specializing in regulation of genetic testing and author of the blog Genomics Law Report, told the Times that some of his clients were holding back tests because it was unclear which would be regulated.

“No one has a clear understanding of where the FDA is drawing the line at this point,” said. Vorhaus.  He said the FDA was “trying to keep up with a commercial space that is moving way faster than they are capable of.”

The House Energy and Commerce Committee is also looking into these tests and sent letters last month to 23andMe, Navigenics and Pathway Genomics requesting extensive information.

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