23andMe, the Mountain View, CA–based consumer DNA testing company that got in hot water with FDA over its lack of PMA approval for its testing for various medically significant genes, now seems to have backed off in its claims enough to appease the agency.
FDA told the company that its responses to the November 22, 2013, Warning Letter “appears to be adequate.” Those responses boiled down to the company eliminating any references to its Personal Genome Service (PGS) having any utility in the “cure, mitigation, treatment, or prevention of disease.”
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