FDA Cracks Down on Genetic Test Kits

Five <"http://www.yourlawyer.com/practice_areas/defective_medical_devices">genetic test kit makers have been told by the U.S. Food & Drug Administration (FDA) they must receive federal approval prior to marketing specific devices to consumers, according Mercury News. The FDA’s letters were posted online last week and point to the agency’s move to step up its handling of companies that market products alleging to predict diseases via DNA samples, specifically inheritable diseases, said Mercury news.

The letters tell each firm their specific products are considered medical devices and, because they are so designated, must receive federal approval for safety and efficacy, wrote Mercury News; none of the firms—23andMe Inc., deCODE Genetics, Illumina, Navigenics, and Knome Inc.—have sought approval, said the FDA.

23andMe Inc., deCODE Genetics, and Illumina market tests that either screen patients for their chance of developing specific health conditions or their response to certain drugs, said Mercury News. Navigenics and Knome Inc. make “high-grade testing and software equipment” used by genetic firms for DNA sample analysis, said Mercury News; these technologies must be reviewed as medical devices, according to the FDA.

The FDA’s letters ask the firms to arrange for submission of the products for review, reported Mercury News, which noted that some companies—it sighted 23andMe as an example—have been selling test kits that use saliva for years and with little overview. While 23andMe stated it would respond to the letter, it disagreed that its tests must receive federal approval, said Mercury News. “We are sensitive to the FDA’s concerns, but we believe that people have a right to know as much about their genes and their bodies as they choose,” 23andMe stated, quoted Mercury News.

When Pathway Genomics announced it would sell its kits through Walgreens, the nation’s largest drugstore chain, offering a lower priced, mass-marketed kit to screen for genes linked to, for instance, “prostate cancer, cystic fibrosis, and diabetes,” the FDA became involved, said Mercury News. Saliva collection kits with full genetic analysis cost $275 from Pathway, while similar 23andMe and Navigenics products sell for anywhere from $400 and $1,000, noted Mercury News. When the FDA told Pathway it never submitted its kits for review, Pathway canceled its plans.

Such testing kits have physicians and public health officials concerned about the data on which the technology is based; there also exists an unclear understanding about how DNA “variations” lead to specific diseases, explained Mercury News. Sign On San Diego pointed out that critics say some parts of these kits are not fully backed by science and DNA test results should be reviewed with a physician.

According to Sign On San Diego last month, a Congressional committee initiated an investigation into the “consumer-direct genetic testing industry” when Pathway began its plans to sell its kit at Walgreens. Members of the House Committee on Energy and Commerce requested significant company records from Pathway, Navigenics, and 23andMe, said Sign On San Diego, with lawmakers requesting, in part, documents on how samples are collected, how results are analyzed, and the accuracy of the firms’ interpretations. The companies had until June 4th to respond, said Sign On San Diego.

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