FDA sends letters to Illumina and genomics suspected of selling unapproved products

FDA has informed four consumer genomics services providers and Illumina that it believes the firms are selling unapproved diagnostic devices, according to a report published by the GenomeWeb Daily News.

Letters were sent 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 state that FDA believes they are using products “intended for use in the diagnosis of disease or other conditions.” Products listed as not having regulatory clearance are Knome’s KnomeComplete offering, 23andMe’s Personal Genome Service, Decode Genetics’ Decodeme Complete Scan, and Navigenics’ Health Compass.

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.

“23andMe is in receipt of the FDA’s letter and will respond directly to the agency,” 23andMe said in a statement. “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.”

FDA has been cracking down on direct-to-consumer (DTC) genetic testing offerings, as exemplified by these letters as well as one that FDA recently sent to Pathway Genomics concerning a genetic testing kit made by the company. The kit, which according to the agency letter required marketing clearance, was already part of a deal with Walgreens. Walgreens was to sell a collection kit for the DTC test product, but the store subsequently put the deal on hold following the FDA’s letter.

FDA’s action prompted the U.S. 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 consumers, 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; and documents relating to the services’ compliance with FDA regulation.

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