The US Food and Drug Administration (FDA) has finally approved a direct-to-consumer genetic screening service into the market, after initially banning the device back in 2013 following concerns about the public health consequences of inaccurate results.
The company 23andMe was founded in 2006 with the goal of bringing genetic testing to the general public. Its saliva testing kits claimed to offer the subject a variety of genetic information from whether you are at risk for some inherited diseases to what parts of the world your ancestry heralds from. On initial release the company was providing results to customers indicating risk levels for 254 diseases and conditions.
Because the reliability of many of those genetic markers were questioned, the FDA pulled the plug on the service in 2013, expressing concern that "assessments for drug responses carry the risks that patients relying on such tests may begin to self-manage their treatments through dose changes or even abandon certain therapies depending on the outcome of the assessment."
The company went on to successfully launch the product and service in the UK and Canada, albeit in a substantially modified condition, while a version of the service that only offered ancestry details continued to operate in the United States.
The latest FDA announcement has allowed the tests to now include genetic risk information on 10 specific diseases and conditions including Alzheimer's, Parkinson's and Celiac disease.
The 23andMe test involves a saliva collection kit that the subject mails back to the company's lab after offering a sample. Within six to eight weeks the company can identify a variety of genetic markers and compile a report that the subject accesses via email.
The FDA is clear in making a distinction between this form of genetic health risk testing and other tests that could be determined as diagnostic. They defined diagnostic tests as those that are often used as the sole basis for major treatment decisions, noting the BRCA genetic tests as primary examples.
The BRCA1 and BRCA1 genes are known as being markers that significantly raise a woman's risk for breast cancer. Currently testing for this gene can only be undertaken through a doctor in order to mitigate and discuss the consequences of a positive reading. It has been argued that indiscriminate access to this kind of genetic testing, without a doctor's supervision and direction, could lead to unnecessarily dramatic patient decisions.
The company currently charge US$99 for its ancestry tests and $199 for the expanded health risk information.