If genetic test makers have their way, consumers will soon be able to test themselves for the likelihood of developing heritable diseases like breast cancer and Alzheimer’s Disease. Companies such as 23andMe Inc., and decode Genetics are currently defending these consumer disease-predicting kits before Food and Drug Administration (FDA) regulators.
For years, these companies have marketed the kits to consumes over the Internet. But a recent crackdown by the FDA has put a stop to the practice. The federal agency asked the firms to submit proposals for review. An expert panel is expected to weigh the risk of marketing these genetic testing kits to patients without the involvement of doctors. They will also consider the scientific standards for direct-to-consumer genetic tests and whether they should be held to the same standard as prescription-only tests.
How DNA variations lead to certain diseases is still a much-researched practice, and the FDA raised concerns that the tests may be inaccurate. Since the tests could be used to make medical decisions, the FDA is pushing for the kits to be regulated as strictly as at-home pregnancy tests.
Genetic kit makers argue that regulators need to be flexible to embrace the benefits of consumer genetic testing. At least one group says its kits will connect consumers with genetic counselors on an as-needed basis.
The FDA panel is expected to give its recommendation later this week. The FDA is not required to follow the wishes of its advisory boards, but it usually does.