July 31, 2012

23andme Seeks FDA Clearance for DTC Genetic Testing Services

In a major development over how genetic testing is to be regulated, a leading personalized genomics company is seeking FDA review for some of its direct to consumer (DTC) genetic tests. 23andme offers genetic testing services directly to its consumers by having them send a saliva sample in a kit to the company for DNA testing, and then receive an analysis of various genetic permuations which may have relevance for diseases or benign traits. There is no medical intermediary between consumer and company. In an announcement on its blog, 23andme stated that it has filed documentation for what is known as 510(k) premarket notification to receive clearance for some of its genetic services. This refers to a review by the FDA of a proposed medical device for similarity to existing devices, or for affirmation that the device does not require any premarket approval and may be marketed. The field of DTC genetic testing has met with official criticism from a number of sources in recent years (see here for background on regulatory conflicts). The Secretary's Advisory Committee on Genetics, Health and Society issued a report in 2010 which found many irregularities in the field, and warned of the dangers to medical consumers who are directly receiviing genetic information that has little reliability and may be making medical decisions based on what they learn.The FDA sent warning letters to a number of genetic testing companies in 2010, including 23andme, advising them that their genetic services, although direct to consumer, met the classification of a device that required FDA approval as medical devices. A Government Accountability Office report and investigation in 2010 found that several companies provided inconsistent results to undercover consumers, and that the information provided also did not line up with the consumer’s actual clinical status. Another watchdog  at the federal level is the Federal Trade Commission, charged with general consumer protection, that has alerted consumers to the possibility that the services offered by these DTC companies are not reliable and consumers may be deceived by marketing claims. However, it is this pending review by the FDA that will have the most impact on the DTC field, partly from the results of the FDA review, but also because of the paradigm shift for the industry that the action by 23andme portends. The industry has long argued that its services were simply laboratory-derived tests (LDTs) that did not require formal review as devices, but simply had to meet the CLIA standards for clinical laboratories. This submission acknowledges the significant demand for FDA involvement in the field of DTC genetic testing, for which it has jurisdiction, but has largely avoided.

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