FDA opens door to direct-to-consumer genetic tests for rare inheritable disease

Federal health officials are easing access to DNA tests used to screen parents for devastating genetic disorders that can be passed on to their children.

The Food and Drug Administration said Thursday it will not require preliminary review before companies can sell the tests directly to consumers. These so-called carrier screening tests are generally used by parents who are considering having children. The announcement comes amid the rise of a fledgling industry aiming to sell consumers personalized genetic information.

In the same announcement, the FDA said it cleared the first carrier screening test from 23andMe, the Google-backed genetic testing firm that previously clashed with regulators. The test screens parents for genetic mutations that cause Bloom syndrome, a rare disorder that causes short stature and a variety of other health problems.