The Food and Drug Administration (FDA) wrote on Thursday allowing direct marketing of 23andMe’s Personal Genome Service Genetic Health Risk (GHR) to assess the genetic risks for ten diseases and conditions. The California-based startup has been under review since 2013 but was met with obstacles. The testing kit has since been revised to cover just ten diseases and conditions, from the 254 the company was aiming to provide when GHR first disrupted the healthcare services.
23andMe
The Silicon Valley startup company was already offering genetic analysis when the FDA issued a warning in 2013.
Some 254 diseases and conditions were analyzed from saliva samples. A warning letter was issued regarding the health interpretation of the data 23andMe was providing. The letter pointed out that the serious risks that the Administration thought were enough to force the company to stop marketing their product, then called the Saliva Collection Kit and Personal Genome Services (PGS). The concerns include the possibility of patients using the results to self-manage, incorrect results, and issues that may lead to serious injury or death.
Associated risks
False positives and false negative findings are some of the risks associated with the use of the GHR test kit, which is not yet in the market. According to the FDA, a user study performed as part of the review process showed that the consumer kit’s test instructions and reports were easy enough to follow and understand.
Participants in the study understood more than 90 percent of what the reports tell them. Anne Wojcicki, 23andMe CEO and co-founder, was happy about the approval, saying that it was a significant step forward for her company and for “the adoption of personal Genetics”. The company will only start releasing the approved test kits this month to its new health and ancestry service customers later this month.
Hereditary conditions or diseases
The GHR isolates DNA from samples that are then tested against 500,000 genetic variants before telling you whether you are at risk for these 10 diseases or conditions: Parkinson’s, Alzheimer, Celiac disease, Alpha-1 Antitrypsin deficiency, Early-Onset Primary Dystonia, Factor XI deficiency, Gaucher disease type 1, G6PD deficiency, Hereditary Hemochromatosis, and Hereditary Thrombophilia.
The FDA decided to exclude 23andMe from providing 'diagnostic tests,' which are often used as the sole basis for major treatment decisions. There are health interpretations that can only be made and thoroughly understood through proper consultations with qualified health professionals.
