The agency warns that consumer-based testing for drug sensitivities may violate FDA rules.
Companies that sell genetic testing directly to consumers have recently come under increased regulatory scrutiny. Now federal regulators are taking a closer look at one company that promises consumers direct information on their genetic risk of developing side effects from certain drugs.
Earlier this week, the Food and Drug Administration (FDA) sent a notice to the biotechnology company DNA4Life, according to Reuters. The agency is concerned that the company’s direct-to-consumer DNA testing, intended to produce information on the patient’s potential sensitivities to certain pharmaceuticals, should be considered a medical device that requires agency approval before it can be sold to the public.
In a statement previously reported by Reuters, the company said it did not believe that FDA approval was necessary for the testing services.
On its website, DNA4Life offers the “drug sensitivity” report for $249. Consumers do not need any medical indication or a physician’s order to receive testing. The company claims that, by screening 12 specific genes for compatibility with more than 120 of the most commonly prescribed drugs, resulting in a report on the patient’s risk of side effects, describing the risk as normal, increased, or extreme.
A company video suggests that knowing this information “could save your life.”
But the FDA and independent scientists have warned that such genetic testing provides limited or no value in predicting side effects, noting that drug interactions may be the result of thousands or more genetic and environmental factors that cannot be identified through the screening of a dozen genes. The agency is also concerned that consumers may misinterpret data from such testing, resulting in questionable and even potentially harmful medical decision-making.
FDA has previously ordered the gene testing firm 23andMe to take its similar DNA screening kits off the market, and only last month allows that company to re-launch a much more limited line of direct-to-consumer tests. The new 23andMe tests approved by FDA do not include drug interaction screenings.
In its letter to DNA4Life, the FDA requested that the company provide information to verify that the testing has been approved or supporting material on why the tests should not be subject to agency regulations.
