DENVER (CBS4) – The Food and Drug Administration has ordered a DNA testing company to stop selling its over-the-counter test. The FDA claims the test is being sold illegally to diagnose diseases with no proof it actually works.
The company, 23andMe, reports it has nearly a half-million genotyped customers but the FDA wants to know if the company is making worrisome promises based on flimsy data.
It’s a genetic test that promises reports on 240 conditions and traits. Through a saliva sample some people have shown on YouTube the company claims people can learn about risks for arthritis, diabetes, cancer and more.
“The goal of having more and more information is really to better be able to predict what is your health outcome going to be,” 23andMe CEO Anne Wojcicki said.
Two years ago Ron and Marilyn Stember of Denver paid $300 apiece for the DNA testing because they were curious about some health issues.
“I have pretty good confidence in the results that I got. It just all matched up,” Ron Stember said.
But Ron Stember was surprised he showed high risk for deep vein thrombosis. Both got word they were predisposed for macular degeneration.
“Since that time I’ve now had confirmation that I have early stage,” Marilyn Stember said.
23andMe has responded to the warning letter recognizing the company hasn’t met the FDA’s timeline expectations on submitting evidence.
“Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns,” the company said in the letter.
The bottom line is the FDA wants the company to show that the technology is supported by science. Experts are worried that false results from the test could cause patients to receive inadequate or inappropriate medical care.