WebMD News from HealthDay
Feb. 20, 2015 -- Americans will soon have easier access to DNA screening tests for serious genetic disorders that can be inherited by their children.
On Thursday, the U.S. Food and Drug Administration said no preliminary review will be required before companies can sell what are known as carrier screening tests directly to the public. The tests -- currently given by health care professionals -- are used by healthy adults who may be carriers of severe genetic disorders such as cystic fibrosis and Tay-Sachs, the Associated Press reported.
The FDA also announced that it authorized the first direct-to-consumer carrier screening test from California-based genetic testing firm 23andMe, which was forced to remove its DNA tests from the market in 2013 due to a lack of scientific proof.
The test from 23andMe screens for genetic mutations behind a rare inherited disorder called Bloom syndrome, which causes short stature, increased risk of cancer and a number of other health problems. The disorder affects about 1 in 50,000 people, the AP reported.
Thursday's FDA announcement means that another 45 to 50 carrier screening tests made by 23andMe could be sold directly to the public, possibly by later this year, according to company CEO Anne Wojcicki.
She said her company's research shows that the general public can understand genetic test results.
"Our user comprehension studies have shown that people can get this information on their own without a physician and that there's potentially a real benefit to direct access," Wojcicki told the AP.
A notice of change about the genetic screening test regulations will be filed by the FDA and the agency will accept public comments for 30 days.
"The FDA believes that in many circumstances it is not necessary for consumers to go through a licensed practitioner to have direct access to their personal genetic information," said Alberto Gutierrez, director of FDA's office for diagnostics, the AP reported.
source : Health Highlights: Feb. 20, 2015
