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Illumina CEO Says Firm in Talks with FDA Regarding 'Regulatory Gray Zone' for Arrays in DTC Genomics

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By Justin Petrone

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.

Flatley noted that regulating the DTC market has proven difficult for the FDA. "Because these arrays are highly complex in terms of the amount of information they provide … the traditional model of how you conduct a clinical trial for demonstrating clinical validity is somewhat challenged," he said.

"What we’re working through with the FDA is how do you come up with some new paradigms that really take into account the fact that these arrays are totally different from the traditional single-analyte test where you run one clinical trial, get one result, and either approve it or not," he said.

"The truth," Flatley said, "is that I don’t think the FDA knows exactly how to go about this." He added that the DTC industry is "working through this regulatory gray zone to try to figure out how it is we can bring these arrays into some degree of compliance and yet at the same time deal with the overall complexity."

Indeed, Flatley's comments came a week after the FDA held a two-day meeting to discuss its strategy for regulating laboratory-developed tests, including those sold by DTC genotyping firms. That meeting was followed by a congressional hearing on DTC genomic testing, in which FDA officials stated that these tests are medical devices and require the agency's clearance or approval.

As reported by BioArray News sister publication Pharmacogenomics Reporter, Jeff Shuren, director of FDA's Center for Devices and Radiological Health, acknowledged at the congressional hearing that the agency waited too long to take regulatory action against the DTC genomics industry. "If there is any issue with the FDA, and I'll say it here … it was why didn't we act sooner, and we should have acted sooner," Shuren said (PGx Reporter 7/28/10).

He added that FDA is considering guidelines that would address the unique features of the DTC genomics industry. "We need an out-of-the-box approach" for DTC genetic firms, Shuren told the committee.

As Illumina discusses the regulatory framework for DTC testing with the FDA it is also holding similar discussions with the agency about the use of its chips in clinical cytogenetics. The FDA held a public meeting in June to address ways in which cytogenetic arrays could achieve regulatory compliance (BAN 7/6/2010). Illumina said in January that it plans to eventually submit a cytogenetics package to the FDA for clearance (BAN 1/26/2010).

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