People can now have their their DNA analyzed for ancestry, physical traits and disease markers using a saliva sample. Photo by 23AndMe
MOUNTAIN VIEW, Calif., Oct. 21 (UPI) -- Controversial genetics startup 23andMe is launching a personal genetic service, or PGS, that allows people to gain insight into their background, traits and whether they are genetic carriers for disease, as well as participate in larger scientific studies, according to the company.
Users can sign up for the service online and, after providing a saliva sample, have access to more than 60 reports based on their own DNA, according to a press release.
The company debuted its service in 2013 but was ordered by the Food and Drug Administration to stop stop including disease risk reports because no evidence had been provided to the agency showing the product was accurate.
At the time, the FDA had worked with 23AndMe for 5 years on studies about the service, originally billed as being able to detect 254 conditions. However, concerns about claims that using it could help people mitigate the existence or risk for "serious diseases" such as diabetes, heart disease and breast cancer led the FDA to demand sales cease pending additional research, according to a letter the agency sent in 2013.
"We are the first company that has gone through the FDA and has a genetic test that is authorized by the FDA to go direct to consumers," Anne Wojcicki, chief executive officer of 23AndMe, told Bloomberg. "I think it's really clear to us now how much we did not know. I look back and I'm really happy we went through those two years. We're a better product now."
The 23AndMe PGS tests for genes that indicate whether a person is a carrier for a disease such as cystic fibrosis, sickle cell anemia or Tay-Sachs disease, among others; can trace a person's ancestry; provides reports on the body's interaction with caffeine, lactose, and alcohol, among other wellness reports; indicates traits; and purports to not only participate but inform people about new genetic research as it relates to their own DNA.
Other tests that indicate genetic risk for diseases such as breast cancer and Alzheimer's are not included in the new version of the test, however Wojcicki said the company is working to meet FDA requirements for those as well. Information from customers also will be entered in a drug discovery database, which the company said it hopes will help further understanding of the effect of genes on diseases.
Some doctors have opposed diagnostic and genetic tests being made available directly to consumers, based on fears they could seek treatment without consulting medical professionals and experts first. 23AndMe includes warnings on many pages of its website that while the information they derive from customers' DNA is not meant to diagnose disease or indicate risk -- merely to tell people what is in their DNA.