The FDA has given genetic testing giant 23andMe the go-ahead to sell a screening kit to tell consumers how well certain drugs will work them.
At the same time, the agency with a stark warning that most genetic tests can't be trusted to fulfill that need.
Direct-to-consumer genetic testing is a hot and controversial topic among doctors, patients and regulators alike.
While proponents say tests like 23andMe give consumers a better understanding of and agency over their own health (at a relatively low price point), skeptics argue that direct-to-consumer medical tests don't paint a complete picture.
And doctors - let alone patients - rarely have the right training to interpret the complex risk factors signaled by genetic variants, experts caution.
The FDA has green-lighted a new DNA test from 23andMe that will tell consumers how their DNA might alter the effectiveness of drugs. Simultaneously, the agency issued a warning that the results should not be used to inform decisions about what medications to take
Some 12 million Americans took at-home genetic tests in 2017.
DNA testing's popularity has its roots in genealogy, but the companies offering the tests are looking to health information as the future of their businesses.
This is putting the Food and Drug Administration (FDA) in an awkward position that is partly of its own making.
Up until 2017, the FDA had every intention of regulating direct-to-consumer DNA tests.
Then, it changed its tune.
After keeping a tight grip on the flow of genetic tests onto the market, Comissioner Scott Gottlieb announced in November of last year that the FDA would let genetic tests 'to be exempted from premarket review under certain conditions.'
And so the flood gates opened, as the FDA bent to complaints that its regulation of the tests would 'bring innovation to a halt,' recalls Dr Peter Lurie, executive director of the Center for Science in the Public Interest (CSPI) and a former FDA insider recalls.
Genetic tests no longer need FDA-approval to be marketed to consumers, but having the agency's seal of approval certainly lends them legitimacy.
And while it has abdicated control over the tests, the FDA is still responsible for warning the public of the potential risks of products, including, it seems, DNA tests.
Now, 23andMe's forthcoming pharmacogenetic test is the first and, thus far, only such kit to get the FDA's approval.
Pharmacogenetic tests screen for a number of genes linked to how individuals respond differently to a variety of drugs.
The 23andMe test purports to provide genetic variation information pertaining to 50 common over-the-counter and prescription medicines.
But the FDA also put out a warning about how this information should be used, and by whom.