The Federal Food and Drug Administration (FDA) of the United States has enacted a major blow to DNA health testing by ordering the popular 23&Me company to halt sales of their home testing kits to the public. The company has received lots of media attention mostly due to its connection to internet giant Google by way of a previous marriage between Google founder Sergey Brin and 23&me’s founder Anne Wojicki. The billion dollar behemoth of the internet world is said to have supplied millions of dollars in seed money to launch the home-based DNA testing business.
In ordering the stoppage of home DNA testing kits for health based information, the FDA has placed a major hurdle in the path of the company’s main avenue for selling DNA testing kits. The kits priced at $99 each, are reported by the company to be able to look into a person’s genetic code to establish the genetic predispositions for heredity diseases such as cancer that may manifest themselves later on in a person’s life. The catchy slogan used on the Silicon Valley based company’s website boldly claims “Strike back before cancer has a chance to strike”.
Health consequences cited as cause
The FDA issued a statement directed to 23&Me stating the company “must immediately discontinue marketing the [the personal genome service] until such time as it received FDA marketing authorization”. The directive has effectively ended all sales of the popular product for the time being. The DNA has made no indication as to when the ban may be lifted or augmented and in a company statement the response was conciliatory. “Our relationship with the FDA is extremely important to us and we are committed fully to engaging with them to address their concerns” and that the company “recognize[s] that we have not met the FDA’s expectations regarding timeline and communication”.
While the statements made regarding the cessation of sales of these health tests to the public are clear in their intention, it is not understood what the fear the FDA has that these tests may expose the public to. The FDA implied that there was a concern that person’s receiving test results may take unneeded or excessive action to remedy a test finding that may potentially cause health consequences.
How health DNA testing works
The process for taking a home DNA test for a health analysis is a more simple procedure than many consumers realize. For often low prices, such as the $99 kit from 23&Me, customers are sent a kit which contains instruments for gathering their saliva. The saliva is then sent to a DNA laboratory for analysis. During the testing, the genetic material contained in the saliva sample will be extracted and mapped. The subsequent DNA profile is then compared against a database which according to DNA companies, will show preliminary tendencies towards certain diseases such as Alzheimer’s or cancer. Most of these testing companies provide a detailed report which will indicate average, above average, or below average risk assessments for the contraction of a myriad of common diseases. The source for the likelihood of a person getting a disease or condition is based on the similarity of their gene structure to other person’s whose medical history is known.
The fear factor in DNA
The fear factor that the FDA has alleged is nothing new. Many in the medical profession have for some time voiced concerns that the information provided in a DNA health test can be flawed, exaggerated or completely errant. The main preoccupation is that consumers will take extreme measures, such as Angela Jolie famously did with her double mastectomy, based wholly on testing which is not fully proven.
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