The Food and Drug Administration has ordering genetic test maker 23andMe to halt sales of its personalized DNA test kits, saying the company has failed to show that the technology is backed by science.
In a warning letter posted online, FDA regulators say the Silicon Valley company is violating federal law because its products claim to identify health risks for more than 250 diseases and health conditions.
Only medical tests that have been cleared by the FDA are permitted to make such claims.
The FDA letter said 23andMe could potentially endanger consumers if, for example, they stop taking medications because a false-positive assessment indicates they have a "sensitivity" to certain drugs. A false-positive genetic assessment could lead women to seek unnecessary treatment for a heightened-risk of breast or ovarian cancer, while a false-negative assessment could result in a failure to recognize that an actual risk may exist, the agency said.
The letter follows years of back-and-forth between the government and Google-backed 23andMe, the most visible company among a new field of startups selling personal genetic information. The proliferation of consumer-marketed genetic tests has troubled many public health officials and doctors who worry that the products are built on flimsy science.
For years, 23andMe resisted government regulation, arguing that it simply provides consumers with information, not a medical service. But last year the company appeared to change course, submitting several of the disease-specific tests included in its test kit.
A spokeswoman for the Mountain View, Calif.-based company said 23andMe recognizes "that we have not met the FDA's expectations," for addressing questions about the submission.
"Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns," said Kendra Cassillo in a statement.
Earlier this month, 7NEWS interviewed Dana Hall, a 19-year-old Colorado woman who submitted a DNA sample to 23andMe to learn more about her family heritage.
"I opened up my box and I was so excited," Hall said. "I was really excited to find out about my ancestry, heritage."
So, she spat into the test tube and shipped it back to be tested by 23andMe.
But some experts raised concerns about firms that do genetic testing without providing consumers with proper genetic counseling to help them make sense of the results.
"There are some ethical issues, but that's not to say that Americans won't go for something that's $99," Dr. Matthew Taylor, of the Adult Medical Genetics Program at CU's School of Medicine, told 7NEWS.
Taylor says the science behind genetics testing is robust, but the problem can come when people interpret the results.
Many genetic diseases are heavily influenced by outside factors like environment and lifestyle. He says that without that context, the results could create unnecessary worry or a false sense of security.
"There are people in the genetics field who are worried that this is genetic testing, and it's done without a physician, and it's done without a genetic counselor," said Taylor.
The tests, including the one offered by 23 and Me, compare an individual's risk compared to others across the population.
"It would be nice to know if you take this drug you are going to get sick, but it really tells you if you take this drug, you might have a slightly higher chance of getting sick than somebody else who takes the drug," Taylor said. "If you want to know what’s going to happen next, this is not that test. That’s the crystal ball test, and that doesn’t exist."
In their blog, 23andMe points to examples of people who have benefitted from the tests, such as a runner who was diagnosed with a rare disease after he got his results.
And as that company continues to grow, they hope to compile a database that will help track disease patterns, find cures and create personal healthcare road maps.
When Hall got her test back, there were a few surprises.
Her ancestry came back as mostly northern European, but without a Y chromosome the results only reflected her mother's Danish ancestry. Her father's side of the family was not included.
"Reading through, I was so nervous just because I didn't want to find out something that could change the course of the rest of my life, even though it's just a genetics test," Hall said.
After working up the courage to read her health risks, Hall found the report indicated she had almost double the average risk for Alzheimer's disease.
"I look at it as a tool that I can use to help my own choices and lifestyle, but I'm not going to take it as something that's 100 percent true," she said.