23andMe receives FDA clearance for at home risk testing for 10 genetic diseases.

23andMe headquarters in Mountain View,California

23andMe become the first ever company that receives FDA clearance for offering consumers at home genetic risk testing for 10 diseases or condition. This is the first direct-to-consumer (DTC) authorization by FDA so that people may know about their genetic predisposition to certain conditions and make lifestyle choices in consultation with health care providers.

Up Till now patients who wanted to get the genetic test done has to see a Physician to order the tests.

“Consumers can now have direct access to certain genetic risk information,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “But 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 results provided by these genetic testing have limitations of not providing total risk estimate of a person because the full expression of genetic variant also depends on environmental and lifestyle factors.

The 23andMe Kit 

23andMe testing kit comes with a saliva collection kit with the instruction manual and a prepaid mailing package to send the sample to the lab. The results are in 6-8 weeks’ time which are viewed by customer by logging in the account. The company's Health and Ancestry test cost $199 to the consumers.

The 10 diseases that will be reported in the test results are Parkinson’s disease, Late-onset Alzheimer’s disease, Early-onset primary dystonia, Factor XI deficiency, Gaucher disease type 1, Glucose-6-Phosphate Dehydrogenase Deficiency Hereditary hemochromatosis, Hereditary thrombophilia, Alpha-1 antitrypsin deficiency and Celiac disease.

23andMe previously marketed a Personal Genome Service in the U.S but in 2013 FDA ordered 23andMe to stop selling its genetic kit to consumers because of lack of enough data to support its accuracy. So, today’s decision was a turnaround for the company.

Today’s market authorization is conditioned on the fact that the current or any future Genetic Health Risk (GHR) test results cannot be used as "diagnostic tool." That means, any major treatment decisions cannot be taken based on the GHR test results.

FDA also required that all test results should be communicated in a way that is easy to interpret and follow. FDA is also requiring 23andMe to provide information to consumers about how to obtain access to a board-certified clinical molecular geneticist or equivalent to assist in pre- and post-test counseling.

The US FDA has already authorized 23andMe’s Bloom Syndrome carrier test in 2015 that will tell the consumers whether they are carrier for autosomal recessive disorders that can be passed to their children.

The FDA announcement was met with criticism by some researchers because they believe that it’s going to increase the dilemmas of people who test positive for any disease or trait. They believed that genetic testing should always be carried out in guidance with an expert and along with the ‘pre-test’ conversation and counselling.

The FDA recent press release can be accessed here.

The FDA 2015 press release for first direct-to-consumer genetic carrier test for Bloom syndrome can be accessed here.