FDA Eases Path to Genetic Disease Screening
The US Food and Drug Administration (FDA) will no longer require preliminary review before companies can sell genetic carrier screening tests to the public.
The health watchdog's unexpected decision, announced late last week, will make it easier for prospective parents to undergo DNA screening for inheritable genetic diseases.
Currently administered by health care professionals, the DNA tests are designed to be used by prospective parents who are healthy but may be carriers of cystic fibrosis, Tay-Sachs and other rare familial conditions.
The decision is seen in particular as a victory for Mountain View, California-based 23andMe to sell directly to consumers. In the same announcement, the FDA said it had cleared the first carrier screening test from the Google-backed company.
In November 2013, the FDA forced 23andMe to stop selling its genetic tests, saying it had failed to show they were backed by science. The agency is said to have also taken issue with 23andMe's aggressive marketing tactics.
The FDA plans to file a notice of the change and will take comments from the public for 30 days. The tests could return to the market later this year.
"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.
Anne Wojcicki, CEO of 23andMe, told US media her company's research demonstrates that patients can understand genetic testing 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 is quoted as saying.
