A Google-backed company that offers a personal genetic screening to test for diseases such as cancer and Parkinson’s will be available in the UK from today despite deep public health concerns in the US.
The Department of Health is warning people that they should “think carefully” before using the £125 genomic assessment as “no test is 100 per cent reliable”.
America’s public health authority, the Food and Drug Administration, banned the company, 23andMe, from predicting people’s future health after failing to prove the tests were accurate.
Now, the California-based company, set up by Anne Wojcicki, the wife of Google’s co-founder Sergey Brin, is launching in the UK amid questions over whether the science is sound and could drive people to seek out unnecessary treatments.
23andMe – named after the 23 pairs of chromosomes in a human cell – offers its customers reports on more than 100 health and personal traits based on genetic tests carried out on saliva samples. It claims that its Personal Genome Service (PGS) can also unveil genetic secrets about an individual’s ancestry – even telling customers what percentage of their DNA comes from Neanderthals.
Globally, 800,000 people have taken the tests, which are already available in the US and Canada. However, customers in the US do not currently receive information on their health after the FDA temporarily banned 23andMe from marketing the test last year.
“Without strong public oversight, we’re back to the era of snake oil,” Marcy Darnovsky, chief executive of the Centre for Genetics and Society, said at the time.
The company says it had addressed the concerns raised by the FDA, and the UK test offers health reports on fewer conditions.
In the UK the service is not being marketed as diagnostic and therefore does not require approval from the Medical and Healthcare Products Regulatory Agency. The products used comply with European safety regulations.
23andMe is one of the biggest and best-known of a growing number of private genetic testing companies. It is part-funded by Google, which was an early investor when the company was founded in 2006. In a statement greeting the service’s arrival in the UK, Ms Wojcicki said that the company’s “mission” was “to ensure that individuals can personally access, understand and benefit from the human genome”.
The tests work by extracting DNA from a saliva sample, submitted by customers to 23andMe’s lab. Data from the DNA is extracted and placed on a “genotyping chip” that can be analysed by a computer. The information is then uploaded to a secure online account that the customer can view.
The UK is already considered a world leader for genetic research. Growing understanding of the genetic basis of a broad range of health conditions is revolutionising health, and experts said that personalised testing of the kind offered by 23andMe would become more common.
“You could argue with ethicists till the cows come home about whether people should be able to have their genomes sequenced,” said Mark Thomas, professor of evolutionary genetics at University College London.
“The bottom line is, technology is taking over. It is here, they are doing it, and it’s not going away.The question is: are these companies responsible? Is the information they are giving you scientifically sound and is it handled in a responsible way?
“Genetics is messy and complicated. If people are expecting their test to say, ‘you’ve got this variant, therefore you’re going to get this disease’, they need to know that this is rarely the way it is.
“23andMe are one of the better companies out there. They’ve got vast resources and Google behind them, and have set up a very professional outfit with some leading scientists on their advisory board.”
However, the company is still unable to offer its health reports to consumers in America, where test results are currently limited to information on ancestry and raw genetic data, after a warning from the FDA a year ago.
The regulator said at the time that 23andMe should “immediately discontinue marketing the tests”, saying it was “concerned about the public health consequences of inaccurate results from the PGS device”. Regulators warned they were not convinced that the firm had “analytically or clinically validated” its test for the intended use of informing customers about their health.
A spokesperson for 23andMe said that the company was working closely with the FDA and that the UK version of the test had been “reformulated” taking US regulators’ concerns into account.
A Department of Health spokesperson said: “This Government is developing the use of genomics for patient care within the NHS. We welcome initiatives that help to raise awareness of genomics and those which enable people to take more interest in their personal health but we urge people to think carefully before using private genomic services as no test is 100 per cent reliable.”
For £125, 23andMe promises to use genotyping technology to analyse DNA in your saliva and reveal a variety of characteristics. While it cannot diagnose disease, it can reveal whether someone possesses a recessive genetic variant of 43 hereditary conditions, including cystic fibrosis and sickle cell anaemia, and any of 11 genetic risk factors for diseases, such as hereditary breast cancer and Parkinson’s disease.
It can also expose 38 physical traits common to a person’s family, such as ear wax type, hair curl and even pain sensitivity. The likeliness of someone having a bad reaction to drugs that treat conditions such hepatitis C and epilepsy can be measured as well.
The data can also be used in genealogical research to establish facts about a client’s ancestry. It can determine facts such as what percentage of their DNA comes from different populations and how closely related they are to Neanderthals. They are also able to match clients to their relatives and are currently working with MyHeritage to create a family-tree tool.
If you are a frequent smoker, the company says the results of tests will help people to learn how their body would respond to diet and exercise, and whether they are predisposed to be a sprinter or endurance athlete.
The Personal Genome Service, it claims, will also look for genes that may be factors for conditions such as blood clotting.