FDA reverses decision on home genetic testing kit developed by Google backed company
The USA’s FDA has officially approved a home genetic test kit developed by 23andMe, after several years of instructing the company to stop providing the service.
The regulator has given the authorisation to a 23andMe kit that tests for gene sequences linked to 10 diseases or conditions that include Alzheimer’s and Parkinson’s disease. A move which is expected to open the door for more direct-to-consumer genetic test approvals.
“Consumers can now have direct access to certain genetic risk information,” said the director of the FDA’s Center for Devices and Radiological Health Jeffrey Shuren, who cautioned: “it is important that people understand that genetic risk is just one piece of the bigger puzzle, it does not mean they will or won’t ultimately develop a disease.”
The reasoning behind FDA’s original decision in 2013 was the potential for confusing consumers, thereby leading the regulator to instruct 23andMe to stop offering the DNA testing kits. However, the company has recently been able to persuade the agency to allow selling kits that would enable consumers to test if a healthy person carries disease genes that could potentially be passed onto future offspring.
The kit entails customers providing a saliva sample that is then mailed to the company for sequencing, which gives insights into the user’s ancestry and genetic makeup. Which will allow US customers for the first time to have access to information relating to their own genetic health risks, an option that the company has been offering to the UK and other countries for several years.
Along with Alzheimer’s and Parkinson’s, the new Genetic Health Risk (GHR) test covers coeliac disease, alpha-1 antitrypsin deficiency, early onset primary dystonia, Factor XI deficiency, type 1 Gaucher disease, glucose-6-phosphate dehydrogenase deficiency, hereditary haemochromatosis and hereditary thrombophilia.
Although the FDA are still cautious about the test, emphasising that as well as the presence or absence of genetic variants there are “many factors that contribute to the development of a health condition, including environmental and lifestyle factors”.
Aside from direct test sales, 23andMe also taps into the genetic database afforded by its estimated two million customers with drug discovery partnerships, including tie-ups with Pfizer and Genentech.