FDA questions asks companies why DNA tests are not medical devices.
Numerous companies now offer consumers gene testing that claims to answer everything from athletic ability to sensitivity to common drugs. In many cases, consumers can simply send a swab of saliva to a testing company and receive a wide array of results based on a genetic analysis.
But many experts say that our current understanding of genetic influences on most of the traits being tested for is far to primitive for making such claims. Now, according to Bloomberg, the Food and Drug Administration (FDA) may be starting to clamp down on the companies’ deceptive practices.
Earlier this month, the agency sent letters to three direct-to-consumer genetic testing firms, warning them that they do not have approval to sell such medical tests.
One company, Interleukin Genetics, has been selling genetic testing designed to guide users in diet and excursive planning. The company DNA-CardioCheck claims its tests can detect consumers’ risk of blood clots that are related to heart disease. The third company, DNA4Life offers testing they say can detect a patient’s risk of side-effects to more than 100 common drugs.
The companies’ tests cost between $169 and $450 per sample. In many cases, consumers can request the tests without a doctors’ order, and may receive the results without the aid of interpretation from a qualified genetic counselor.
The market for genetic testing is skyrocketing, with one analysis showing that there are already nearly 3,000 such tests available. Testing companies see huge potential profits from DNA analysis, with one project showing the sector growing at 10 percent annually.
For now, FDA has not ordered the three companies to stop selling their tests, but has asked them to provide a rationale for why the tests should not be considered medical devices that fall under the agency’s regulatory purview.
FDA has previously ordered the gene testing firm 23andMe, founded by the ex-wife of Google founder Sergey Brin, to stop marketing its direct-to-consumer medical tests, although recently the agency has allowed that company to relaunch a small fraction of its medical test offerings.
