Considering a home DNA test? Think again. An undercover operation by federal investigators has found the results of genetic testing kits appear misleading and unreliable for predicting inheritable diseases. The key finding was the tests basically provide consumers little to no useful information.
For many people, genetic tests may sound like a dream come true. Imagine being able to know, years in advance, that you’re predisposed to inheritable conditions including breast cancer and Alzheimer’s disease. The saliva-based test kits are called “personalized medicine of the future” and a way to test your “health, disease and ancestry profile.” The ads claim you can “take charge of your health” for fees ranging from about $300 to $1,000.
These tests have been sold online for years, but began attracting federal scrutiny in May when Pathway Genomics announced plans to market its products in retail pharmacies. The Food and Drug Administration stopped those plans, saying the tests had to undergo federal testing. The undercover investigation followed.
The Government Accountability Office (GAO) submitted DNA samples from five staff members to four different genetic testing companies. All claimed to be able to provide information to help manage health conditions based on a personal DNA analysis. Test results included contradictory predictions based on the same person’s DNA as well as results that were at odds with actual medical histories.
The companies' results contradicted each other nearly 70 percent of the time for the same diseases, according to GAO. In response to the same patient's DNA, one company claimed he was at above-average risk for prostate cancer, a second said he was below average and two others said his risks were average.
"Consumers need to know that today, genetic testing for certain diseases appears to be more of an art than a science," said GAO investigator Gregory Kutz, in testimony before a House Energy and Commerce Subcommittee. The GAO presented its findings at a Congressional hearing held last week to scrutinize the personalized genetic industry, which until recently operated below the radar of federal regulators.