A controversial mail order test that provides individuals with details about various health risks based on their genes has gone on sale in the UK, despite serious concerns.
The test, which costs £125 ($196), was created by California-based company 23andMe but is backed by Google. All people have to do is spit in a tube and send the samples in the post to the company. DNA within the saliva is then analyzed by scientists, and a health report is sent back around a month later.
According to the company’s website, the test looks at over 100 different health conditions and traits, such as whether you possess gene variants associated with abnormal blood clotting. It also searches for genetic risk factors for a variety of conditions, such as cystic fibrosis or Parkinson’s disease. You can also find out whether you might be lactose intolerant, or how your body may respond to various medications and drugs, including caffeine. People can also use it to trace their ancestry, and identify potential relatives if they have also taken the test.
While this Postal Genome Service (PGS) may sound great on paper, the test has sent alarm bells ringing in many. The kit was available in the US long before it reached the UK, but the Food and Drug Administration (FDA) has already banned 23andMe from advertising the product in the US following questions over accuracy and reliability. The FDA claim that the company failed to provide adequate information to back up its claims, and consequently 23andMe no longer offers tests related to health in the US.
Despite all of this, and the fact that the FDA is still “concerned about the public health consequences of inaccurate results from the PGS,” the test has now been launched in the UK. Although the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has said that the test will be regulated to ensure it meets minimum standards, only the kit is subject to regulation, not the test itself. The MHRA has also stressed that these tests are not 100% reliable and should be treated with caution.
The UK Department of Health also says that the service offered in the UK is not the same as what was originally provided to US customers. Formerly, information was given on genetic risks for more than 250 conditions, including those associated with heart disease and some cancers. However, a significant number have been removed because of issues over accuracy and concerns that people may make life decisions based on the results without first consulting doctors.
As pointed out by Dr. Marcy Darnovsky, executive director of the Center for Genetics and Society in California, while genetic tests are important diagnostic tools, they’re pretty useless as a method to predict complex diseases in healthy people. 23andMe also stress that the tests are intended for informational purposes only, and that many diseases are influenced by multiple factors, including social and environmental. Simply having a particular variant of a gene therefore does not mean that you will likely develop a certain condition.