FDA-Mandated Withdrawal of 23andMe’s Personal Genome Service

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On November 22, 2013, the US Food and Drug Administration (FDA) took the surprising step of ordering 23andMe, a genomics company, to cease marketing its flagship Personal Genome Service (PGS). The PGS is a DNA sequencing product marketed directly to consumers that claims to “help individuals and their doctors identify health areas that they need to keep an eye on.” By determining the presence of certain single-nucleotide polymorphisms, the PGS estimates risk for more than 250 diseases and health conditions by extrapolating from research studies. After initially continuing to sell its product, 23andMe heeded the FDA’s warning letter and stopped offering health-related genetic tests on December 6, 2013.

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One Response

  1. GregEdwards says:

    The FDA express concerns that those receiving the partial genetic predisposition information from a 23andme test will act irrationally or preemptively but look at the case of one women who showed 1 or 2 BRAC indicators for breast cancer….here 23andme clearly advised the positives on the BRAC markers should be a discussion to pursue with her doctor. In reality a responsible physician would next recommend the patient get another, targeted and more comprehensive genetic test for BRAC 100s of other markers. That is exactly what Huffington Post blogger Jill Steinberg did when her 23andMe results came back showing that she carried one of the BRCA mutations. The additional DNA tests confirmed the 23andMe finding, and she eventually decided to have a preventive double mastectomy. She dodged a bullet that the FDA would have left her in the path of. A dear friend has recently been diagnosed with an aggressive BRAC related breast cancer in her 30s and I would do anything to have lead her sooner to 23andme to give her a chance the FDA thinks she should not have.
    On the other hand what someone had not shown the marker on the 23andme test? Well the FDA has cleared HIV testing with error rates (missed positives as high as 1 in 12! So clearly the FDA is not about getting us accurate information but rather the typical bureaucratic stance to say no because it validates their power. (Political-Sci Public Policy 101!)
    Remember, this is our DNA, and we have a right to any service that responsibly advises us that any additional information they might give us is not complete but should be a subject for further discussion and investigation. As a 23andme DNA customer, I applaud them for the insights they have given me and admonish the FDA for their posturing on our behalf. Inform us, do not act for us! Where is the idea of public service as opposed to intervention?

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