The FDA has just issued a warning letter to 23andMe on the 22nd November 2013 to cease their direct-to-consumer marketing of the Saliva Collection Kit and Personal Genome Service (PGS) as it has no FDA clearance.
23andMe launched its services in 2007 and continued to grow in the genetic testing market. It claims to have continued active engagement with the FDA prior to launching the test offering. The company managed to secure over 160 million in investments and has been steadily growing over the past 6 years reaching over a million tests performed. So where is a problem with what they do? Let’s look at a few more past issues that the company came across.
Back in 2010 23andMe was one of the three companies asked by the Committee on Energy and Commerce of the United States House of Representatives to provide information about their services. 23andMe claimed at the time that genetic information provided to individuals helps them take control of their own health and it is a critical part of the personalized medicine. In the same year 23andMe asked the Commissioner of the FDA, Dr. M. Hamburg and the Director of the NIH, Dr. F. Collins, to engage with them on developing reporting standards. In July 2012 23andMe applied for an FDA clearance of their services, at the moment the FDA claims that certain issues still have not been addressed by the company. What else does the other side claim? The FDA alleges that it provided adequate feedback on study designs and despite the efforts is still not certain that the test is appropriately validated. Primary concern for the FDA is that patients will use the results of this test to make medical decisions including self-medication or invasive surgery for breast cancer.
While it seems that 23andMe has some serious questions to address, there are other questions that need some clearing up. Namely, what technologies are used by the genetic testing companies and how reliable are they? We know what technology is used by Illumina, who just got its premarket clearance for MiSeqDx Cystic Fibrosis and Universal kit. 23andMe also uses Illumina platform but instead of sequencing it analyses SNPs in our DNA. On the other hand two other companies providing the same or similar tests to 23andMe, Pathway Genomics and Counsyl do not publicize the technology they use on their websites. Such information should be required by the FDA to be publicly available, as not all technologies are equal and lack of agreement between results can be in some cases due to the method used rather than any other reasons.
Ok so what does that mean for consumers? They are probably the most confused group in this whole discussion. Should they or should not they be using the tests, and those who have done them, should they believe in them or not? Research groups apparently are trying to stay clear of 23andMe results. So why is there such a big problem with the data? SNP analysis is well established as a genetic screening method, however, analysis of the data is still a big problem. We know very little about allele frequency in some populations or modifiers that can affect if we get a disease or not. Testing too few markers can be insufficient to provide proper information about our disease risks. Additionally, the results obtained from the test are not always independently validated. Why? Companies with complex tests are telling us that their results are accurate and there is no need to check them, costs of running additional confirmation are high, medical professionals are not requesting those confirmations… We can go on speculating on the reasons. Best solution to move towards solving the problem is to critically evaluate the data and studies performed, see how the different companies deal with the same set of samples.
What is the solution for the customers? If you have been tested by any company and are confused, talk to your family doctor and they will be able to put you in touch with a genetic counselor or medical geneticist who can review and explain results, and if needed order follow up tests to rest your mind. In meantime learn more, ask questions before getting tested and most certainly after.
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