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In All Fairness…

Dan Vorhaus at the Genomics Law Report says that the US Food and Drug Administration has issued 14 additional letters to providers of genetic tests — to Interleukin Genetics, Sequenom, and SeqWright DNA Technology Services, among others — in a continuation of the agencies "crackdown on direct-to-consumer" firms. The letters, Vorhaus writes, are "similar" to those the FDA has sent to 23andMe, Navigenics, DeCode Genetics, Knome, and Illumina in that they suggest the firms are "marketing a genetic test that, according to the FDA, meets the definition of a 'device' under Section 201(h) of the Federal Food Drug and Cosmetic," though they aren't as lengthy. The 14 companies that received letters must respond to the FDA within 15 days, the blogger writes, whereas the five previous letters "urged the companies to 'take prompt action to respond' to the letter, instead of setting out a definite timeframe." In listing each of the 14 companies the FDA has contacted, and the specific genetic tests in question, Vorhaus suggests that "the range of tests and test providers makes it impossible to determine why or how the FDA selected these particular tests for the current round of letters." For example, he says, Matrix Genomics, which the FDA has contacted concerning its breast cancer panel, also offers tests for Alzheimer's disease and warfarin dosing, among others.

As reported by our sister publication, GenomeWeb Daily News, "the committee hearing in the House Subcommittee on Oversight and Investigation today is scheduled to hear from GAO officials on their investigation of the genetic testing market, from FDA on its ongoing actions, and from representatives from 23andMe, Navigenics, and Pathway Genomics."

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