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23andMe Asks FDA To Approve Some Tests

Publication Date: 
July 30, 2012
Source: 
San Francisco Chronicle
Author: 
Victoria Colliver

Professor Mark A. Lemley is quoted in the following San Francisco Chronicle article by Victoria Colliver on a genetic testing company's request to have the FDA approve its consumer tests.


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.

...

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.