Genetic Testing Company 23andMe Becomes First Direct-To-Consumer Service Approved By FDA

J.E. Reich, Tech Times 21 October 2015, 02:10 pm

Two years after placing a ban on the company 23andMe's marketing of health reports within DNA analysis tests the company offered, the U.S. Food and Drug Administration (FDA) has reversed course, approving the selling of testing kits by the firm. Despite the fact that the approval makes 23andMe the first direct-to-consumer testing service, it comes with a price.

While the company has now been granted permission to market and sell kits that test for around 36 genetic diseases (among them Tay-Sachs, cystic fibrosis and sickle cell anemia), complete with accompanying reports, the victory wasn't especially surprising — and far from a landslide win. While the FDA first began to finally approve of the company's proferrings back in Feb. 2015, when it allowed 23andMe's Bloom Syndrome Carrier Status test, the 36 granted tests are only out of 250 the company requested.

The FDA's shutdown on 23andMe's services back in 2013 was originally due to a lack of "marketing clearance or approval," according to the federal agency. This was also due in part to the fact that direct-to-consumer testing services were more or less a taboo, especially in relation to result accuracy.

As per 23andMe founder Annie Wojcicki (whose former husband and company financier was none other than Google co-founder Sergey Brin), the FDA ban had a drastic and devastating effect on the company's subscriptions, essentially cutting their clientele in half.

So, how did 23andMe win back the FDA's favor? From "working from within the system and saying the consumer will have a sense of ownership and a voice in that system," Wojcicki told The New York Times in an exclusive (and perhaps partially due to its recent foray into drug development). According to a press statement released on Oct. 21 about the decision:

"We invested nearly two years of work conducting extensive user testing, working with regulators, scientists, physicians, and top product design experts. Most important, we talked to 23andMe customers about how we could improve functionality, comprehension and create tools to improve your experience."

Then again, there are some downsides: 23andMe is upping the price of its kits from $99 to $199; the hike is most likely caused by "the investment in drug development, [which] might prevent [23andMe] from turning a profit in the short term," reported NYT.

For more information about 23andMe's services, check out the video below.