On November 22, the US Food and Drug Administration sent a letter to the direct-to-consumer genomics company 23andMe. 23andMe is well-pedigreed startup with at least $161 million of funding from Google and other leading technology investors. Their service offers a personal genetic analysis that promises to “find out if your children are at risk for inherited conditions, so you can plan for the health of your family.”
In their letter, the FDA takes aim precisely at these types of claims: “to date, 23andMe has failed to provide adequate information to support a determination that the PGS (23andMe’s Personal Genome Service) is substantially equivalent to a legally marketed predicate for any of the uses for which you are marketing it.” The FDA is calling into question both the accuracy and reliability of the data produced by 23andMe’s genetic analysis, expressing concern that a misinterpretation of the results could lead to very real negative health outcomes. The FDA cites the potential for false positives — which could lead to patients undertaking unnecessary or potentially dangerous treatments — and false negatives, which could result in a patient ignoring a potentially fatal disease.
Genecloud is also a technology service aimed at the market for analysis of genetic data, albeit one with significant differences from 23andMe. While 23andMe develops its own algorithms for analysis of genetic data and presents the results directly to consumers, Genecloud is a platform for securely bringing together genetic data and analysis software. Development of genetic analysis algorithms is not limited to Genecloud itself; the platform is open to the entire world of genetic researchers.
Genecloud ensures both the security and privacy of sensitive genetic data by carefully controlling access to the data and to the programs that analyze it. The data do not have to be in the physical possession of a researcher, which would introduce a risk of unauthorized disclosure. Rather, researchers create programs to produce the results they want, which are moved by Genecloud to the point where the data actually resides and run on that sensitive data under policies set by the stakeholders in the data. Genecloud ensures that programs report their results only to those authorized to receive them.
Genecloud’s platform can be used to create a system that should address many of the FDA’s concerns around personal genome services. First, the algorithms used to analyze genomic data could be limited to those which are certified (by appropriate authorities) as being medically valid. Second, to ensure that the results of this analysis are interpreted properly, the results would only be released to a medical professional designated by the customer. By making sure that the consumer receives genetic information only from medically certified genetic analysis algorithms and the results have been interpreted and disseminated through a medical professional, we believe the chances for the kinds of mistakes and misinterpretations which concern the FDA can be greatly diminished, allowing the new science of genomics to scale to its full potential in treating human disease.