A device that offers personal genetic screening for diseases such as Parkinson's has been allowed by UK regulators, despite being banned in the US.
The Google-backed company 23andMe says that its home DNA testing kits will allow users to discover whether or not they are genetically predisposed to certain diseases.
US regulators have ruled that the device should not be sold, so why has it been passed by the UK's Medicines and Healthcare Products Regulatory Agency (MHRA)?
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What is it?
The 23andMe test kit costs £125 and promises to reveal genetic characteristics by analysing the DNA in a person's saliva. The kits can be ordered online and require users to take a saliva sample, which is then sent to a laboratory in the Netherlands for testing. Results will take up to eight weeks and can be viewed online.
The company stresses that the test does not diagnose disease, but says DNA analysis can predict whether a person has a recessive genetic variant for some hereditary conditions such as cystic fibrosis or genetic risk factors for diseases such as Parkinson's. The developers say the information they provide will help people to "take steps towards living a healthier life".
Why is it controversial?
In 2013, the company was ordered to discontinue the sale of kits by the US Food and Drug Administration (FDA) after regulators said they were concerned about "the public health consequences of inaccurate results".
It said that patients relying on such tests "may begin to self-manage their treatment through dose changes or even abandon certain therapies depending on the outcome of the assessment," The Guardian reports.
Dr Marcy Darnovsky, executive director of the Center for Genetics and Society in California agrees with the FDA's decisions, telling the BBC that while genetic testing "is an important medical tool in certain situations" it is "pretty useless" for healthy people as a way of predicting common complex diseases.
Test results could cause "inappropriate harm simply through people worrying excessively or becoming neurotic over these small increases in risk", warns Dr Ewan Birney, associate director of the EMBL-European Bioinformatics Institute in Cambridge.
Experts also have privacy concerns about the data gathered and how it could be used. Professor Hank Greely, director of the Center for Law and the Biosciences at Stanford University in California says: "It's not entirely clear what their business plan is, whether they want to make money by selling kits to consumers, or whether they want to make most of their money by selling consumer data to other companies".
So why is it allowed here?
As the device is not being marketed as a diagnostic test, it does not need approval from the MHRA, The Independent reports. The company stresses that it has worked with the MHRA and says "they have determined that we're not a medical product, more an information product".
A spokesperson from 23andMe said that the tests had been "reformulated" and that "many of the drug responses, inherited conditions and genetic health risks that were of concern in the US have been removed".
The MHRA says that although the product met minimum safety standards, patients should "think carefully" before using such devices.
