San Francisco Bay Area biotech stories.
Monday, July 30, 2012
23andMe seeks FDA clearance of DNA analysis test
Consumer genetic testing company 23andMe Inc. submitted paperwork to the Food and Drug Administration for clearance of its personal genome service, it said Monday
. It is the first step toward 510(k) clearance for medical devices, the Mountain View company said on its
"The Spittoon" blog
. The company also said it believes it is the first direct-to-consumer genetic testing service to publicly acknowledge that it is trying to win FDA clearance.
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