23andMe asks FDA for some test approval - San Francisco Chronicle

In a step that could pave the way for the fledgling genetic testing industry, 23andMe is seeking approval from the U.S. Food and Drug Administration for a series of personalized tests the Mountain View company offers directly to consumers.

23andMe, which was named for the 23 pairs of chromosomes in the human body, on Monday announced it had submitted an initial batch of seven health-related tests to the FDA for approval - a move that comes after years of resisting such regulation. The company plans to submit applications covering more than 100 tests in the coming months.

"FDA clearance is an important step on the path toward getting genetic information integrated with routine medical care," said 23andMe Chief Executive Officer and co-founder Anne Wojcicki, who is married to Google Inc. co-founder Sergey Brin.

The FDA has tangled with 23andMe and other direct-to-consumer testing companies in the past.

The FDA sent letters in June 2010 to 23andMe as well as four other testing companies including Foster City's Navigenics Inc. warning them that their products were medical tests and that they had to submit them for review and approval. A month earlier, the FDA had quashed plans for another company, Pathway Genomics in San Diego, to sell testing kits through Walgreens stores nationwide.

The company initially held that its tests simply provided consumers with information, but did not amount to a medical service.

While 23andMe's FDA submission appears to be a shift in strategy, officials from the privately held firm say the decision is more of an evolution than a change. The number of tests offered through the company, which started at 14 when the company was founded in 2007, has mushroomed to more than 200 as genomic science advanced. They gauge everything from the likelihood of developing Parkinson's disease to whether a person carries a mutation that causes cystic fibrosis.

"The reason we have made the submissions and have also made that public is we want to progress the confidence in the genetics testing market generally," said Ashley Gould, 23andMe's chief legal officer, adding that the company wants to lead the way in the new process.

"Everyone should trust the data they're getting, and we're hoping this process will increase this trust," she said.

The FDA has 90 days to respond to 23andMe's application, which was submitted June 29. Gould did not know how long the process would take.

Hank Greely, a Stanford law professor who specializes in ethical, legal and social issues related to biosciences, said consumers should have reassurance that the tests they're getting are appropriate, safe and effective.

"I am heartened by the fact 23andMe seems to agree with that," Greely said.

The FDA regulates some tests - like home pregnancy kits - but not all tests that are conducted in certified testing laboratories like those used by 23andMe, he said. Greely said it's unclear how the regulation of this young industry will play out.

"The one thing that's clear is 23andMe, despite its past, is now saying 'yes, there's a role for regulation,' " he said. "What's not clear is if 23andMe's idea how to regulate this stuff is the same as the FDA's."