The US Food and Drug Administration (FDA) has told five genetic test manufacturers that their products need the agency's blessing before they can be sold to consumers. On June 10th, the agency sent letters to Illumina, of San Diego, Pathway Genomics also of San Diego, NaviGenics, 23andMe and deCODE Genetics, of Reykjavik, Iceland, explaining that their genetic tests are considered medical devices and must be approved. The FDA had no specific plans to regulate these direct-to-consumer tests until recently when Pathway Genomics announced its intention to market a kit at pharmacy chain Walgreens. Customers would buy the Pathway Genomics' Insight Saliva Collection Kit at most of Walgreen's 7,500 stores for $20 to $30 and send their saliva sample to Pathway to undergo what the company terms “comprehensive genotyping.” They could then order individualized Genetic Insight Reports for Drug Response ($79), Pre-Pregnancy Planning ($179), Health Conditions ($179) or a combination of all three ($249). The FDA quickly sent a letter to Pathway stating that agency staffers were “unable to identify any Food and Drug Administration clearance or approval number,” for the kits, a clear indication that they expected to find that. Pathway responded that their laboratory is Clinical Laboratory Improvement Amendments (CLIA)-approved, which they believed sufficient. That little scuffle prompted Walgreens to announce that it would postpone offering the kits “until we have further clarity on this matter.” The furor even caught the interest of Congress. The House Energy and Commerce Committee requested information about their tests from Pathway, 23 and Me, of Mountain View, and Navigenics of Foster City, both in California. After many months of regulatory uncertainty, the FDA's stance is welcome (Nat. Biotech, 27, 875, 2009). All of these companies have been selling such services from their websites for more than a year and will be allowed to continue. But it appears that the agency will no longer be satisfied with just CLIA certification for genotyping facilities, which is how most of these firms operate. According to an e-mail from Dick Thompson of the FDA Office of Public Affairs, “The agency has been meeting with several companies to understand their claims and business models.” The FDA will hold a public meeting on July 19 and 20 to discuss how the agency will oversee laboratory-developed tests.
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Allison, M. Genetic testing clamp down. Nat Biotechnol 28, 633 (2010). https://doi.org/10.1038/nbt0710-633b
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DOI: https://doi.org/10.1038/nbt0710-633b
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