23andMe Personal Genome Service claims to offer access to more than 100 pieces of genetic information about a person's health, ancestry and family traits.
A home DNA kit is being offered for sale in the U.K., and its availability is being met with controversy. According to BBC News, the personal DNA kit uses saliva to screen individuals for major diseases such as Parkinson’s and cancer. For £125, an individual gets a kit to deposit their sample. The sample is then returned to the lab where it will be screened.
Though this sounds like a convenient use of modern medical advances, the company behind the test does not have the most pristine track record. 23andMe Personal Genome Service claims to offer access to more than 100 pieces of genetic information about a person’s health, ancestry and family traits. However, the company was not allowed to market the test in the U.S. after there were questions raised about its accuracy. 23andMe now states on its website that it provides ancestry-related genetic reports and uninterpreted raw genetic data and no longer provides health-related genetic reports.
In a warning letter issued in November 2013, the U.S. Food and Drug Administration (FDA) stated that the personal DNA kit was being sold without marketing clearance or approval. The FDA also notes that, despite numerous interactions with 23andMe, there is no assurance that the firm has analytically or clinically validated the test for its intended uses. As a result, the FDA required 23andMe to immediately stop marketing the test, until it receives approval for the intended uses from the FDA.
The National Human Genome Research Institute states that the human genome contains 23 pairs of chromosomes that are made up of deoxyribonucleic acid (DNA) base pairs arranged in a specific sequence. Only 0.4 percent of the human genome differs between individuals. The potential for genomics lies in unlocking how these differences impact disease prevention and treatment.