Pathway Genomics’ decision to sell its personal genetic health disposition test in Walgreens Drug Stores attracted the attention of the U.S. Food and Drug Administration, which until now has not seemed keen to regulate over-the counter genetic tests. This may soon change.

“Whether it is a genetic test or not, selling a test over the counter without an FDA clearance or approval, particularly for the type of claims they have is not legal,” said Alberto Gutierrez, Director of the FDA Office of In Vitro Diagnostic Device, Evaluation and Safety division, in an interview with the Associated Press.

 

The FDA wasted no time in informing the privately-held San Diego-based company that it had no paperwork to support having cleared its Genetic Health Report, a direct-to-consumer spit kit that is sent back to the company to be analyzed for genetic risk for more than 70 health conditions.

 

In its letter to Pathway Genomics, the FDA said that its test appears to meet the definition of a device and requested a response within 15 days if it didn’t believe it was required to obtain clearance.

 

Pathway Genomics says its test is not subject to FDA clearance. The company has been selling it on its website for almost a year without attracting the FDA’s attention. Walgreens has decided to postpone selling Pathway’s personal genetic test until the matter is settled.

 

Regulation of genetic tests has been a murky area. As it now stands, the FDA regulates only those tests sold as diagnostics devices—manufactured by one company and then sold as a kit to a laboratory for genetic testing. Tests sold and performed by the same laboratory, which includes most direct-to-consumer tests, are not regulated.

Most laboratories are subject to quality control by Centers for Medicare and Medicaid Services under the Clinical Laboratory Improvement Amendment. A handful of tests have been submitted and approved by the FDA, but most direct-to-consumer genetic tests are not submitted, exploiting a loophole in FDA regulations because they are not actually medical devices. 

 

Many scientists are also skeptical about the usefulness of direct-to-consumer genetic tests, especially ones that claim to be able to assess health risks. The American Medical Association has recommended that genetic testing be carried out under the supervision of a qualified health care professional and asked that physicians be provided with more information on the types of genetic tests available so that they can effectively counsel their patients.

 

Other scientists have argued that the information currently provided by many direct-to-consumer tests is merely recreational and question whether or not the average consumer has the ability to interpret the results or needs professional counsel to reach the right conclusions regarding complex genetic information.

 

It is unclear how this current scenario will play out. The FDA has never publicly announced any regulatory guidance with respect to direct-to-consumer genetic tests. Many similar tests from more established firms like Navigenics and 23andMe are sold online. 23andMe’s genetic test is available through Amazon.com. It seems unlikely that the FDA will be able to make a case for regulating Pathway’s test based solely on the test being on a drugstore shelf, but it will open the door to some serious discussion and eventual regulation of a growing area.