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article imageRegulators in UK approve controversial California-based DNA test

By Kev Hedges     Dec 2, 2014 in Science
A personal DNA test kit that has been criticised and was controversial in the U.S., has now been given the green light to be used by U.K. customers following approval from regulators.
The 23andMe spit test gives details on a person's health risks based on the results taken from their DNA. The U.K. regulatory body, Medicines and Healthcare Products Regulatory Agency (MHRA), decided it can be used in Britain providing caution was taken.
Critics of the spit test in the United States say the results of the test may not be accurate enough to base important health issues on. But the company, 23andMe, say otherwise. The Californian-based firm stand firmly behind its testing methods and accuracy of results.
The test aims to offer customers a detailed report of health risks based on the gene variants found in the DNA. But the marketing of its service was banned in the U.S. in November 2013 by the Food and Drug Administration (FDA). The regulatory body said 23andMe could not support the claims it was making with sufficient evidence.
It was in December 2013 that the company stopped offering genetic testing related to health risk reports. But the MHRA in Britain said minimum standards must be met and that it will regulate these tests. A spokesperson for the regulatory body urged clients to remember that no test is ever 100 percent accurate and to "think carefully before using personal genome services."
Google has invested millions of dollars into the company and the CEO at 23andMe is Anne Wojcicki, who is married to Sergey Brin, the co-founder of Google. The concerns at the FDA were that some customers might make life-changing decisions based on the outcome of their personal results received back from 23andMe.
There are also concerns of the testing from those worried about privacy. If the company sells a million test kits a year, it would make around $100 million. But that figure seems small fry by biotech industry standards and Forbes' commentator Matthew Herper believes the data it could gather the test results would be worth billions more.
Much of the information contained in the results of the personal genome test include traits, inherited conditions, how you would respond to drugs, health risks and health tools. There is also an ancestry overview showing composition and paternal and maternal lines going back to one's Neanderthal DNA composition.
More about MHRA approval, personal DNA test, 23andMe, Anne Wojcicki, Google support
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