Senator Chuck Schumer (D-New York) is warning consumers to think before they buy mail-order DNA testing services this holiday season.
Schumer cautions that these test kits put consumer privacy at risk because DNA firms could potentially sell personal and genetic information. Now Schumer is calling on the Federal Trade Commission to investigate and ensure that the privacy policies are clear, transparent, and fair to consumers, according to a statement released by Schumer’s office.
"When it comes to protecting consumers’ privacy from at-home DNA test kit services, the federal government is behind,” Schumer said. “Besides, putting your most personal genetic information in the hands of third parties for their exclusive use raises a lot of concerns, from the potential for discrimination by employers all the way to health insurance. That's why I am asking the Federal Trade Commission to take a serious look at this relatively new kind of service and ensure that these companies have clear, fair privacy policies and standards for all kinds of at-home DNA test kits. We don't want to impede research but we also don't want to empower those looking to make a fast buck or an unfair judgement off your genetic information. We can find the right balance here, and we must.”
Consumers may not realize that their personal information could end up in the hand of third party companies, said Schumer. Each company has its own set of Terms of Service. Some of the language is so vague that there is no concrete understanding of if the personal information could be sold or who the information could be sold to, according to the statement from Schumer’s office.
DNA home testing has become increasingly popular in recent years. In April the FDA allowed the popular genetics test 23andMe to market directly to consumers, which was a first for the industry. 23andMe was one of the pioneers in the industry and had some major hurdles early on. In 2013, the FDA instructed the company to immediately stop selling its testing service before it got clearance because of the lack of evidence to support the efficacy of the test. The company then went through clinical validation testing in order to get FDA approval.
Now there is a plethora of genetic tests on the market. Through partnerships, companies promise to use genetic data for everything from giving consumers insights about their disease risk to helping them choose the perfect wine. Experts have offered mixed reviews of the products—calling some safe and reliable and others based on weak science.
Big name institutions are also jumping onboard the home testing wagon. Genetics testing company Helix partnered with the Icahn School of Medicine at Mount Sinai and National Geographic to deploy Helix’s Illuminia-powered genetic testing service.
In November FDA Commissioner Scott Gottlieb announced that the agency intends to change its regulatory process around direct-to-consumer genetic health risk tests. The change would allow companies to bypass premarket certification for individual tests once they submit to a one-time review of their process.
As for Schumer’s view of the future, he said he doesn’t want to stop the advancements of genetic testing completely, just to set up a framework.
“The last gift any of us want to give away this holiday seasons is our most personal and sensitive information, so that is why we are asking the FTC to step in, take a hard look at this industry and ensure there are across-the-board protections to safeguard consumers and ensure good research continues,” said Schumer.