What are the dangers of using DNA kit testing for health concerns?
Millions of Americans are submitting their DNA samples directly to labs, with promises of not only ancestry information but also detailed accounts of their likelihood to contract hereditary diseases.
Popularity of what’s known as direct-to-consumer tests has exploded in recent years, according to an analysis by the MIT Technology Review in February. Nine million Americans have submitted samples to the website 23andMe as of January 2019, a website that has had a push-and-pull relationship with the federal Food and Drug Administration about its marketing claims tied to health testing.
Some of those customers then call medical labs staffed by geneticists looking for confirmation of results. So many, in fact, that the University of Washington Medical Center’s Genetic Medicine Clinic had to create a policy that those calls couldn’t be accepted, said Fuki Marie Hisama, the clinic’s medical director.
“The results are not medically valid,” Hisama said.
The FDA agreed in 2013, sending 23andMe a letter warning the company that it was pushing the bounds of what was allowed in the advertising of their products. Since then, the California-based firm has worked with the FDA to receive authorization for its test results indicating the risk of breast cancer and how certain medications will interact with the customer’s genetic makeup, but even those tests are limited compared to a genetic laboratory staffed by medical professionals, Hisama said.
“23andMe only tests for three known mutations, out of the thousands that are possible,” Hisama said of the breast cancer test. “Our testing tests for the thousand possible clinically.”
Along with other geneticists in Seattle and California, Hisama published a warning in the journal Genetics in Medicine last June that such limited testing could give customers, who’ve paid anywhere from $60 to $200 for an at-home test that can be purchased at major retailers like Walmart, Walgreens and Target, a false sense of security. One patient who underwent surgery to remove the risk of breast cancer later submitted one of the kits, which showed she had a “low risk” of breast cancer.
“Fortunately, based on her family history, which included a sister diagnosed with breast cancer prior to age 40 years, this patient was referred to a genetics clinic, and correctly counseled that her lifetime risk of breast and ovarian cancer was higher than average,” the authors wrote. “Because similar cases may not come to the attention of a genetics clinic, the frequency of these occurrences cannot be estimated.”
For its part, 23andMe includes required disclaimers from the FDA indicating that its information should not be used solely to make healthcare decisions, and should be verified through a physician that also includes family history and other factors.
There’s concern that even genetic testing taking place in controlled laboratories may lead to false positives based on errors made by doctors interpreting the results. Women in Oregon and Kansas City have recently come forward saying they received life-changing surgeries based on test results that later turned out to be false positive indicators of future health problems.
Then there’s the potential for data hacking at the private companies offering direct-to-consumer kits and that the information could be used by insurance companies when customers go to buy disability or life insurance policies. Though a federal law passed in 2008 prevents insurers from denying health coverage or raising premiums based on genetic testing information, the law doesn’t cover some plans for small business employees or those in certain federal jobs, including the military, the U.S. Department of Health and Human Services warns.
“It is unclear whether genetic information, including the results of direct-to-consumer genetic testing, will become a standard part of the risk assessment that insurance companies undertake when making coverage decisions,” the department wrote on its website in 2018.