FDA To Oversee Genetic Test Kits Aimed at Consumers
Last week, FDA sent letters informing five genetic testing companies that their products are considered medical devices and therefore must receive agency approval before they can be marketed to consumers. The companies targeted by theÂ letters include 23andMe in Mountain View, Illumina in San Diego and Navigenics in Foster City. Last month, FDA sent a similar letter to San Diego-based Pathway Genomics after the firm announced plans to sell its genetic testing kits at Walgreen stores.
- "FDA To Monitor Genetic Testing" (Johnson, San Jose Mercury News, 6/12).
- "FDA Says Genetic Tests Need Approval" (Perrone, AP/Ventura County Star, 6/12).