Top DNA testing company has been banned from selling its popular test.
It was only a few weeks ago that I was discussing this hot topic with my flatmate. Private companies are selling a direct-to-consumer service that scans your genome for disease-associated variations in your DNA sequence. Who wouldn’t want to know their future risk of developing a disease? If the appropriate preventative measures are taken now then perhaps disease onset can be delayed? Coming from a non-Biology background, my flatmate was easily swayed by the attractive advertising campaign. I, on the other hand, was not so easily persuaded and it now seems neither was the US Food and Drug Administration (FDA).
The end of 23andme?
‘Personalised medicine’ is a major buzzword in the biomedical research world. We are all aware diseases will affect us in one way or another. Private companies take advantage of this vulnerability and the simplistic view that genes are directly associated with disease. Formed in 2006 and financially backed by Google, 23andMe is one of these opportunistic companies that offer personal genetic screening tests to determine your health risks and ancestry. On their website they advertise their saliva-based genetic screening kit for the attractive sum of $99 (£61). However, after failing to provide evidence supporting the reliability and safety of their service, the FDA has now banned 23andme from marketing and selling its kits. It now has one last chance to step up to the plate, otherwise next week will mark the end of 23andme. In my opinion, it seems highly unlikely they will receive the final seal of approval.
The ‘worried well’
Routine genetic tests are of course used for Huntington’s disease and hereditary breast cancer as these rare diseases are linked to specific genes. However, common diseases such as those of the heart and Type 2 diabetes are caused by the interaction of environmental and genetic factors, so most genetic anomalies have no functional significance. The accuracy of such kits is also questionable with the likelihood of false positive and false negative results. So what real benefit would the results offer consumers? The results may be helpful for some but for others they may cause emotional distress and turn otherwise healthy people into the ‘worried well’ – individuals who believe they are at a higher risk for disease than they really are. One customer reveals his psychological torment after 23andme misinterpreted his test results and led him to believe he would develop a potentially life-threatening disease. There is also the possibility of genetic discrimination in employment or health and life insurance. Finally, many genetic conditions lack treatment strategies so maybe what you don’t know won’t hurt you.
23andme has also been criticised for a recently accepted patent for their Family Traits Inheritance Calculator aimed at prospective parents. The company claims this method predicts characteristics such as height, weight, eye colour and personality of future offspring as well as their risks of inheriting diseases. The patent, however, also suggests the acquired data could be used by fertility clinics to shop for desirable donors and essentially create ‘designer babies’. Would you like to pick your child’s traits from a drop-down menu on a website? I certainly wouldn’t.
At this moment in time, these companies have bitten off more than they can chew. The public should not waste their time and money on these services. If you have a family history of a rare genetic disease then a specific genetic test can be performed at a clinic or hospital. Until the reliability and safety of DNA testing are significantly improved, all interpreted results should be taken with a pinch of salt.
Chua EW, & Kennedy MA (2012). Current State and Future Prospects of Direct-to-Consumer Pharmacogenetics. Frontiers in pharmacology, 3 PMID: 22934000
Valles SA (2012). Should direct-to-consumer personalized genomic medicine remain unregulated?: a rebuttal of the defenses. Perspectives in biology and medicine, 55 (2), 250-65 PMID: 22643762