23andMe Baby Gene Tests Get FDA Approval

By Alyssa Camille Azanza - 22 Oct '15 09:14AM

Biotech company 23andMe is now allowed to let actual and future parents in the US know if they might pass a disease to their children with a simple spit test.

Now that they are approved by FDA, the company has relaunched some of its DNA test kits. Their prospective list of 'screenable' conditions is now restricted to 36 diseases, an 85 percent reduction in screening coverage compared to the past services.

The test will also tell people whether they are predisposed to a whole list of traits, from male pattern baldness to lactose intolerance.

The approval means the company's customers will now be able to use inexpensive testing kits to determine their "carrier status," which looks at whether they possess a gene mutation that, when combined with an identical gene mutation in a partner.

Before its dispute with FDA, 23andMe has a direct-to-consumer model that provided raw genetic info to consumers without the guidance of doctors and health counselors to interpret the results. The approach worried the FDA who raised concerns over the test results, if they were incorrect or misinterpreted by consumers. In November 2013, the FDA said that the company's Personal Genome Service required regulatory approval. In its warning letter to 23andMe, the FDA stated it was "concerned about the public health consequences of inaccurate results from the P.G.S. device."

The FDA also said the company repeatedly failed to address its concerns over its service that could moderate the risks involved. 23andMe stated that the company has since submitted studies to the FDA that showed consumers could understand their tests results.

"This is an incredibly dynamic time in genetics and we're excited to be at the leading edge of bringing genetics directly to individuals as they begin to learn about their 23 pairs of chromosomes," said 23andMe co-founder and CEO Anne Wojcicki in a statement.

"Today we've successfully established a framework for working with the FDA to bring back reports directly to the consumer," Wojcicki said. "And we'll continue to work to try and bring all of this information back."