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FDA calls for genetic tests crackdown

[Quotes CGS's Jesse Reynolds]

by David GellesFinancial Times
June 13th, 2010

The US Food and Drug Administration has called for regulation of companies selling personal genetic tests after one laboratory mixed up the results of nearly 100 clients.

The Silicon Valley company 23andMe, which uses personal genetic tests to predict hereditary diseases, last week said that it gave 96 clients inaccurate information after a lab error. The mistake left one client believing that her son was not her own, while another was led to understand that she was of African origin while the rest of her family is Caucasian.

The gaffe raised questions about the ethics and safety of personal genetic testing - a nascent industry - as doctors and advocates warned that inaccurate results could prompt patients to make potentially life-threatening changes to their medications. "There is a real risk in these mix-ups," said Jesse Reynolds of the Center for Genetics and Society. "Incorrect data can have serious implications, such as inaccurate beliefs about the potential to develop serious diseases and what medications one should take."

The company declined a request for interview but said on its website: "We fully realise the gravity of this incident."

Anne Wojcicki, the wife of Google co-founder Sergey Brin, set up 23andMe, which is backed with funding from Google and Genentech. It collects saliva samples from customers, then analyses their DNA for about $500.

The results can provide insight into a person's genetic composition and warn of potential risks of inherited disease, but they are not meant to influence medical treatments.

Such companies have so far operated free from regulatory oversight. However, on Friday, the FDA sent letters to five genetic testing companies, including 23andMe, asking them to submit their tests for approval.

The FDA said: "This premarket review of medical devices enables the FDA to protect the public from medical products that may pose an unreasonable risk of harm. It is important that they be analytically and clinically accurate so that individuals are not misled by incorrect test results or unsupported clinical interpretations."

Doctors welcomed the FDA's move but experts said that, despite the concerns, personal genetic testing was likely to proliferate. "There are always things to be ironed out in new technologies," said Sharon Terry, president of Genetic Alliance, an advocacy group.

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