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

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.

The letters are very similar in their message to the firms that FDA believes they are using products "intended for use in the diagnosis of disease or other conditions." It cited Knome's KnomeComplete offering, 23andMe's Personal Genome Service, Decode Genetics' Decodeme Complete Scan, and Navigenics' Health Compass as not having regulatory clearance.

The FDA has told the firms that they should "take prompt action" to reply to the agency. "If you would like to meet with us to discuss whether there are tests you are promoting that do not require review by FDA and what information you would need to submit in order for your product to be legally marketed for the other uses, let us know and we will schedule a meeting with you," the agency wrote in the letters.

"23andMe is in receipt of the FDA's letter and will respond directly to the agency," 23andMe said in a statement today. "It is important to note that we disagree with the FDA's conclusion. Regardless, we have always been open to discussions to formulate a rational way to regulate the personal genetics industry, and we look forward to continuing those discussions with the FDA."

The letters are the latest action taken by FDA to crack down on direct-to-consumer genetic test offerings that it believes are in violation of regulations. Recently, the agency sent a letter to Pathway Genomics informing the firm that its genetic testing kit requires marketing clearance from the agency. The firm had inked a deal with pharmacy chain Walgreens to sell a collection kit for the DTC test product, but Walgreens subsequently put the deal on hold following the FDA's letter.

The FDA's action spurred the US Congress to open an investigation into DTC genomics providers. The House Committee on Energy and Commerce sent letters to three firms — Pathway Genomics, 23andMe, and Navigenics — requesting information on several aspects of the tests they sell directly to the consumer, including the specific diseases and drugs for which the services provide genomic risk data; policy documents and materials on genetic counseling or physician consultation; data showing the accuracy of the risk predictions delivered by these services; details on policies regarding handling of DNA samples; as well as documents relating to the services' compliance with FDA regulation.

The FDA has yet to any formal guidelines specific to DTC genomics firms, but it has always said it has the authority to regulate these services.

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