We will continue to work with Illumina as our discussion with the FDA continues.
I’ve requested further clarification.
I’ve been hearing ominous rumours that the FDA is planning to completely choke off the supply of genotyping chips to direct-to-consumer genomics companies. GenomeWeb reports that the FDA met with Illumina last week (following its letter to the company back in June) to discuss the company’s supply of genotyping products to DTC companies:
Illumina CEO Jay Flatley said last week that the company is in discussions with the US Food and Drug Administration regarding its supply of arrays to firms that conduct direct-to-consumer genetic testing.
During a conference call to discuss the company’s second-quarter financial results (see story, this issue), Flatley said that Illumina met with the FDA during the quarter to discuss the regulatory framework for DTC genotyping, and that the company intends to “fully comply with the FDA’s guidance.”
He noted that the revenue Illumina currently generates from sales of arrays to the DTC market is “immaterial.”
Illumina was the sole array vendor to receive a letter in June when the agency contacted 23andMe, Navigenics, Decode Genetics, and Knome about their services (BAN 6/15/2010).
According to the letter, which was addressed to Flatley, Illumina was contacted because 23andMe and Decode use its research-use-only Infinium HumanHap550 array in their direct-to-consumer genetic-testing service. In the letters, all dated June 10, the FDA asserts that the gene-analysis systems the companies are using are medical devices and therefore need to be approved by the agency. The FDA, which cites section 201(h) of the Food, Drug, and Cosmetic Act, 21 USC 321(h), urges the firms to contact it to obtain information that would enable them to “legally market” their services.
Either way, it’s clear that the FDA does intend to target DTC companies via chip providers. Let me spell out the implications: if the FDA has “requested” that Illumina stop supplying its chips to DTC companies, Illumina will “fully comply” – the company has little choice but to stay in the FDA’s good books if it wants to move heavily into the US diagnostic market. Illumina supplies chips used by 23andMe and deCODEme, so both these companies would lose their ability to genotype customers as soon as their current supply contracts run out.