Wednesday, December 3, 2014

23 and Me Approved for Genetic Testing in UK


On November 22nd, 2013 the genetic testing company 23 and Me was warned by the FDA to cease sales of genetic testing due to marketing disease testing without the FDA's approval. The FDA wanted this to cease because it could cause people to make life-changing medical decisions without knowledge of whether the information given was potentially falsely positive or negative. This could cause risks to people who choose to make decisions based on the testing that may be risky and dangerous. These decisions could be made even if the disease may not present itself in the person, and it could be deemed unnecessary risk. Today, 23 and me is not allowed to provide medical information, and instead provides only raw genetic data and heritage information. The alert on it's main page states "23 and me provides ancestry-related genetic reports and uninterpreted raw genetic data. We no longer offer our health-related genetic reports."




Health alert and Health Page on U.S site (https://www.23andme.com/)
In the UK however, 23 and me has just been announced to be approved for sale. They are to be used for further genetic and health information, but are warned to be taken with caution. The information given reports genetic results of over 100 genetic diseases such as Parkinson's disease genes and breast cancer genes. The U.K decided that knowing this information and making the informed decision on health care is up to the purchaser, while the U.S does not allow for purchasers to know the information at all.
Health Information Provided by Genetic Testing in U.K. (https://www.23andme.com/en-gb/)
Unfortunately, the U.K genetic tests are only available to U.K citizens, and are not available for purchase by American citizens. Genetic testing and knowing the risk factors for diseases that are deadly or degenerative could have a huge impact on treatment. Many diseases are more easily treated or even prevented by having prior knowledge of their existence. A double mastectomy for breast cancer could prevent the cancer from ever occurring in those who have both affected genes. Since the vast majority of those with the genes end up with the disease by 70 years old, solving the problem now could prevent ever having to suffer through chemotherapy and having to make horrible life decisions. It could even prevent deaths to those with advanced breast cancer.

The decision to make health care decisions has almost always been in the hands of the affected individual. To take that away now is to take away the human right to know what is going on with your own life. With informed medical guidance and proper decision making, these genetic tests could save lives. And if they ever come back on sale in the United States, I'll be one of the first ones to get mine done.

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