Is the FDA planning to strangle the supply lines of direct-to-consumer genomics companies?

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__Update 14:35 EDT 04/08/10: I just received a phone call from a 23andMe representative indicating that these rumours are not true; more details to follow once I have a written statement.__Update 17:26 EDT 04/08/10: __Here is the written statement from 23andMe's PR firm:> We will continue to work with Illumina as our discussion with the FDA continues.

I've requested further clarification.

Update 17:59 EDT 04/08/10: I've received a (slightly) longer written statement from 23andMe clarifying that they have "no reason to believe there will be an interruption in the supply of Illumina chips at this time".- - - - - -

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.

The rumour on the grapevine is that Illumina will soon be discontinuing its supply of chips to DTC providers, if it hasn't already. However, I've also heard indications to the contrary, so I'll provide updates as and when I find out anything official.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.

Moreover, it's unlikely that other chip suppliers (such as Affymetrix) would provide an alternative source: as Mya Thomae notes, "FDA could have sent that letter to dozens of companies, but they only needed to publicize one in order to put *all *suppliers on notice." Like Illumina, Affymetrix won't jeopardise its relationship with the FDA to save its tiny income stream from DTC providers.With their chip supply strangled, DTC companies will be completely at the mercy of whatever the FDA demands. If the FDA decides it wants to kill off the DTC industry entirely, forcing the industry to move towards the physician-only route (as Navigenics and Pathway Genomics have done already), it can do it. If it wants DTC companies to abandon all disease risk prediction and move to exclusively ancestry/genealogy products, they will have no choice but to comply.In addition, targeting chip manufacturers means the FDA can reach far beyond the US. Any DTC genomics company, whether it operates from Silicon Valley or Shenzhen, currently relies on genotyping products from these large suppliers.I'll update you if anything new emerges.