Silicon Valley-based genetic testing firm 23andMe finally broke their silence on the public warning letter issued by the US Food and Drug Administration (FDA) to stop selling its genetic testing kit.
23andMe Chief Executive Officer Anne Wojcicki said they have worked extensively with their lab partner to ensure the accuracy of their results. Wojcicki said, "We stand behind the data that we return to customers - but we recognize that the FDA needs to be convinced of the quality of our data as well."
The public warning letter dated November 22 from the FDA said that 23andMe was marketing its Saliva Collection Kit and Personal Genome Service or PGS without the agency's approval, which was violative of the Federal Food, Drug and Cosmetic Act (FD & C Act). The FDA said that the intended uses for the PGS that were shown on 23andMe's website are for medical devices under the FD & C Act which require the agency's premarket approval. The letter particularly expressed concern about the health consequences that an erroneous result could bring. In its website, 23andMe claimed that its product is able to give results for more than 240 health conditions and traits.
Wojcicki said that this is new territory for her company and the US regulator, adding that the regulatory process with the FDA was important since the work they are with the agency will help lay the groundwork for what other companies in this new industry later on.
In a report on VentureBeat, Christina Farr wrote that there was no clear-cut answer to the matter, with the current case touching on such issues like freedom of information, privacy, proper medical device classification and the balance that exists between innovation and regulation. The FDA has also not given a clear regulation on firms like 23andMe that market their products directly to consumers but the company's increased marketing efforts seems to have provoked the agency, the report added.
23andMe is backed by Google Inc.
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