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FDA to consider regulating genetic testing next week

Today there are more than 100 companies offering some form of genetic analysis and many others that are in the process of developing similar tests. The growing prevalence of products, potential ethical issues and lack of data on error rates has triggered a review of the tests by the Food and Drug Administration.

Next Monday, a two-day meeting begins wherein FDA officials will consider input form test makers, academic experts, clinicians and others on how the agency should regulate these tests.

An article in MIT Technology Review underscores why the public meeting reflects a turning point:

The early generation of genetic tests was relatively simple, testing for a single cancer-linked gene, for example. The possible treatment decisions or other responses were well-defined. But in the last few years, these tests have incorporated more genes and tackled more complex and common diseases...

...The agency says it plans to take a risk-based approach, meaning that tests linked to major medical decisions will be more tightly regulated than those that might predict a minor increase in risk for disease.

The meeting begins at 8:00 a.m. ET on Monday. You can watch the webcast of the first day here and the second day here.

In the meantime, you can also listen to Sandra Soo-Jin Lee, PhD, a senior research scholar and medical anthropologist at the Stanford Center for Biomedical Ethics, discuss why she believes there is an increasingly urgent need for a clear set of rules and regulations governing genetic ancestry testing.

Previously: Whole genome sequencing data vaults into clinic, Learning more about the human genome and Over-the-counter genetic tests are a bad idea, Stanford expert says

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