23andME DNA spit screening test approved and launched in the UK
Genetics company 23andMe is launching its Personal Genome Service to the UK market despite having been banned in its home country, the USA. The Google-backed genotyping service will allow members of the public to have their DNA analysed. This, in addition to providing customers with an overview of their genetic ancestry, can screen and reveal risk factors for common genetic diseases such as sickle cell anemia, cystic fibrosis, Alzheimer’s disease and Parkinson’s disease.
The company does highlight that its services are not diagnostic, in its UK press release, perhaps cautious of the troubles that have beleaguered the company in the US. 23andME had been banned from offering disease analysis in the US in November 2013 until it received the medical device classification it needed as a result of a suspension enforced by the Food and Drug Administration (FDA).
“After many interactions with 23andMe, we still do not have any assurance that the firm has analytically or clinically validated the personal genomic service for its intended uses,” the agency said, amid worries that the result could lead people to making life-changing decisions.
Since the company has yet to provide evidence of research and studies required by the FDA to back up claims billing itself as a “first step in prevention” which helps users in “mitigating serious diseases”, it has continued offer its ancestry-related reports and “uninterpreted raw genetic data” to its customers with approval.
“We can take complicated genetic information and distill it in language that people can actually understand,” 23andMe chief executive Anne Wojcicki said. “The genome is fascinating, and it’s the most exciting scientific revolution of our lifetime. The goal is to keep people engaged with their own genome, so that they know what it means for them and then keep them abreast of the scientific discoveries as they unfold.”
The spit kits will cost £125 a pop and samples are sent to a lab in Netherlands for testing. Customers will have to wait six to eight weeks for the result before they receive more than 100 health-related reports along with the ability to browse raw code of their genome. Alongside more serious results, the company also provides more light hearted genetic results such as earwax type and if you are likely to develop a flush when you drink alcohol. Users who receive a positive result from genes associated with a serious condition would still need to go to their GP and get re-tested for a conclusive result.
The company hopes to run its Personal Genome Service alongside Genomics England’s 100,000 Genome project. This is a government-backed project that aims to sequence 100,000 genomes of NHS patients in England by 2018, and in return unravelling three billion letters of their genetic code to help identify, tackle and predict future diseases.
Lastly, those in the US who are trying to get round the FDA’s sales block could be disappointed again, as 23andMe says that it will only accept orders only from a UK computer IP address, with warehouse instructed to only ship its kits to a legitimate UK address. For UK customers, the kits are available and will ship from today.