A personal DNA testing product that has been banned by the Food and Drug Administration (FDA) in the US has reached the UK.
The DNA testing kit is marketed by California-based company 23andMe, and uses a spit test to offer genetic details about a person’s health, based on their DNA.
The company has come under fire from the FDA as they have not yet completed the necessary studies and provided the results of these studies to show that the test can support a consumer market.
The UK’s healthcare governing body – Medicines and Healthcare Products Regulatory Agency (MHRA) has allowed the product to be sold here in Britain but has issued an advisory notice that it should be used with caution.
A spokesperson for the MHRA said:
“People who use these products should ensure that they are CE marked and remember that no test is 100% reliable so think carefully before using personal genome services.
“If after using the service, you have any questions or concerns you should speak to your healthcare professional.”
She added: “If you are concerned that you have an incorrect result due to a faulty product, you can report this to MHRA at email@example.com or 020 3080 7080.”
DNA Test Cost
The DNA test costs £125 and works by the consumer registering the specific barcode on the pack of the box and then providing a spit sample, which is then sent back to the laboratory and processed. The company provides data on the consumer’s risks for 254 diseases and conditions, including breast cancer and heart disease. There is also information as to how the individual might react to certain medications.
Chief executive of 23andMe Anne Wojcicki said: “The UK is a world leader in genomics and we are very excited to offer a product specifically for UK customers.”
Ms Wojcicki is now separated from the co-founder of Google – Sergey Brin, which coincidently has invested millions in the company.
Although the DNA tests have failed to gain approval from the FDA, the product that has been launched in the UK is quite different to what was offered in the US.
“Many of the drug responses, inherited conditions and genetic health risks that were of concern in the US have been removed,” a spokesperson told BBC News.
Dr Marcy Darnovsky, executive director of the Center for Genetics and Society in California, said:
“Genetic testing is an important medical tool in certain situations, but for healthy people as a way to predict common complex diseases, it’s pretty useless,” she told BBC News.
“Most complex diseases and almost all the common ones – with some exceptions such as the BRCA 1 and 2 genes (implicated in breast cancer) – are multi-factorial with many genes and other biological, social and environmental causes.”
What happens to the DNA data collected
There is a question as to what happens to the DNA data collected by 23andMe once the tests have been completed.
“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,” Prof Greely told BBC News.
But Ms Wojcicki insists that the product is to enable people to access their own personal genetic data:
“23andMe’s mission is to ensure that individuals can personally access, understand and benefit from the human genome,” she said.
Mixed responses on Personal DNA test
Experts on DNA testing have had mixed responses to the product, with Mark Thomas, professor of evolutionary genetics at University College London, stating:
“For better or worse, direct-to-the-consumer genetic testing companies are here to stay. One could argue the rights and wrongs of such companies existing, but I suspect that ship has sailed.”
And a spokesperson for the Alzheimer’s Society saying: “‘If you are worried about your memory, your GP should be the first port of call – not a home DNA testing kit. Research has identified a number of genes that may play a role in the development of dementia but we don’t know enough to use these as a diagnostic tool.”
For more information visit 23andMe.com
Source: BBC News