FDA OKs direct-to-consumer genetic carrier test

The company's CEO said 23andMe is happy to be able to move forward after a nearly two-year standoff with federal regulators.
By Brooks Hays  |  Feb. 20, 2015 at 1:04 PM
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MOUNTAIN VIEW, Calif., Feb. 20 (UPI) -- If you carried a risk of a rare genetic disorder, would you want to know about it? A lot of people do, apparently. Which is why 23andMe Inc., a genetic-testing company backed by Google, is in business.

This week, the Food and Drug Administration approved the company's direct-to-consumer genetic carrier test for market -- a stark reversal of opinion. In 2013, regulators sent 23andMe a letter warning the company to stop marketing its DNA health analysis offerings until further review.

But FDA officials announced Thursday they are exempting genetic carrier screening from premarket reviews, paving the way for products similar to 23andMe's to enter the market. The new FDA decision will be subject to a 30-day public comment period before it is finalized.

"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," Alberto Gutierrez, who heads up the FDA's Office of In Vitro Diagnostics and Radiological Health, said in a press release.

"Today's authorization and accompanying classification, along with FDA's intent to exempt these devices from FDA premarket review, supports innovation and will ultimately benefit consumers," Guiterrez added. "These tests have the potential to provide people with information about possible mutations in their genes that could be passed on to their children."

Anne Wojcicki, the CEO of 23andMe, said she and her company are happy to be able to move forward after a nearly two-year standoff with regulators.

"It shows the F.D.A. is willing and supportive of crafting the direct-to-consumer path," Wokcicki told The New York Times. "It's a very reasonable first step. I would go so far as saying it's a very generous first step."

Before it was ordered to stop, 23andMe's main genetic test was for Bloom syndrome. Consumers would send a saliva sample through the mail, and 23andMe would send back a detailed DNA analysis.

Bloom syndrome is a disorder characterized by short stature, skin redness and a predisposition to the development of cancer. In order for someone to develop Bloom syndrome, they must inherit two genes, one from each of their parents. Disorders that require the pairing of two mutations are called autosomal recessive diseases.

The Bloom syndrome test, like all carrier tests, can alert adults as to whether or not they carry the relevant gene. If two otherwise healthy parents pass on a single gene mutation corresponding to a rare disorder, their children will develop said disorder.

One of the most common autosomal recessive diseases is cystic fibrosis, a disorder that affects the lungs and causes breathing difficulties and lung infections.

The Silicon Valley-based company, 23andMe, wouldn't confirm when their genetic carrier tests would go back on the market, but suggested they would likely begin offering health analysis services again sometime this year.

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