FDA to regulate new generation of diagnostic tests

The FDA is taking steps toward regulating genetic diagnostic tests. The agency has released draft guidelines of the new regulations, which supporters say should help validate the tests for consumers. On the other hand, critics maintain that the FDA's decision to step into the field will raise costs and discourage the development of new tests. Diagnostic tests sold to labs and doctors are already under the FDA's control as medical devices. But tests used at home, such as predictive tests for breast cancer, are not. The number of those "home brew" tests is expected to soar. These diagnostic tests will play a big role in the development of more personalized medicines, a specialty of the biotech industry.

- read The New York Times article [1] on the FDA guidelines