Direct-to-consumer (DTC) genetic tests now on the market may be getting ahead of the current medical science and could ironically pose health risks to those patients who may change their medical care based on those results, according to a new Government Accountability Office (GAO) study and testimony presented late last week before a House panel.
In 2006, GAO investigated several companies selling DTC genetic tests and testified that these firms made medically unproven disease predictions. Flash forward four years later: new companies have since been touted as being more reputable, but some experts remain concerned about test results be misleading consumers, the report states.
GAO purchased 10 tests each from four companies, for $299 to $999 per test. It then selected five donors and sent two DNA samples from each donor to each company: one using factual information about the donor and one using fictitious information, such as related to age, race, or ethnicity.
The results, according to Gregory Kutz, GAO's Managing Director of Forensic Audits and Special Investigations, were that fictitious consumers received test results that were "misleading and of little or no practical use."
As one example, GAO's fictitious donors often received disease risk predictions that varied across the four companies providing the tests—indicating that identical DNA samples were yielding contradictory results, Kutz told the House Energy and Commerce Subcommittee on Oversight and Investigations.
GAO's donors had received DNA-based disease predictions that conflicted with their actual medical conditions. For instance, one donor who had a pacemaker implanted 13 years earlier to treat an irregular heartbeat was told that he was at decreased risk for developing such a condition. However, none of the companies could provide GAO's fictitious African American and Asian donors with complete test results, but did not explicitly disclose this limitation prior to purchase
Marketing genetic tests directly to consumers could increase risks to patients because they may make decisions that adversely affect their health—such as stopping or changing the dose of a medication or continuing an unhealthy lifestyle "without the intervention of a learned intermediary," Jeffrey Shuren, MD, director of the Food and Drug Administration's Center for Devices and Radiological Health, told the House panel.
Since then, changes have been seen in the number and types of claims being made. For example, one company provided test results for 17 diseases, conditions, or traits in 2008; however, in 2010. it provided over 100 types of results, Shuren said. In particular, some companies are making claims about high?risk medical indications, such as determining the risk for cancer or the likelihood of responding to a specific drug.
Although the experts GAO spoke with said they believed that these tests show promise for the future, consumers should not rely on any of the results at this time, the report states. GAO says it has referred all the companies it investigated to the Food and Drug Administration and Federal Trade Commission for appropriate action.
Janice Simmons is a senior editor and Washington, DC, correspondent for HealthLeaders Media Online. She can be reached at jsimmons@healthleadersmedia.com.