US Regulators Try to Tame 'Wild West' of DNA Testing
By Erika Check Hayden,
Nature News
| 02. 20. 2015
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Genetic testing has entered a new realm, with the ability to read a person's genetic code and predict how it will affect his or her health. But US regulators are struggling to work out how the tests should be governed, with a particular sticking point being who decides what the genetic read-outs mean in terms of health and disease.
So far, the US Food and Drug Administration (FDA) has approved genetic tests only for specific conditions. This includes the approval on 19 February of a test developed by 23andMe of Mountain View, California, to determine whether people carry a gene variant that could lead to their offspring developing Bloom syndrome, a rare disorder characterized by small stature and multiple health problems.
With the massive number of genome-based diagnostics that are possible, the agency cannot practically continue with the painstaking approach it has taken in approving these tests. So on 20 February, the FDA is running a workshop at which scientists, doctors and regulators will discuss a strategy put forward by the agency in December that aims to allow...
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