FDA Warns Consumer Genomics Firms, Illumina on Selling Unapproved Dx Products | GenomeWeb

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has sent letters to four consumer genomics services providers and Illumina saying that it believes the firms are selling unapproved diagnostic devices.

The agency sent letters yesterday to Knome, 23andMe, Decode Genetics, and Navigenics. Illumina also received a letter because Decode and 23andMe use the firm's Infinium HumanHap550 arrays in providing genetic information to their customers.

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