FDA Proposing to Ease DTC Genetic Tests' Path to Market

The US Food and Drug Administration (FDA) is proposing to ease the approval process for direct-to-consumer genetic tests, saying that the diagnostics can increase consumer engagement in their health.

"In its consideration of [genetic health risk] tests, the FDA seeks to strike a balance that provides for an efficient pathway to bring these tests to consumers, without sacrificing the assurances offered by FDA oversight," said Commissioner Scott Gottlieb, MD, in a statement.

"As consumer interest in genetic risk information grows, opportunities are also expanding for the detection of additional genetic conditions and diseases that can help inform people of their medical risks," Dr Gottlieb said.

But, he noted, the agency is not overlooking the risks associated with the tests, "especially if they provide consumers with incorrect or misleading information that may be used to make health choices without considering the advice of a medical professional." A potential downside, said Dr Gottlieb: "Consider the consequences of a person who is told they're not at risk for coronary heart disease and incorrectly opts to forgo dietary changes or drugs that reduce their risk of heart attack and death."

The proposal comes on the heels of what the agency considers a positive experience with the first genetic health risk (GHR) tests — marketed by 23andMe — which were approved in April. That maker's GHR tests — which isolate DNA from saliva — provide genetic risk information, but can't determine an individual's overall risk of developing a disease or condition.

The agency on November 6 said in a final notice that, in the future, any new 23andMe tests would not have to be reviewed before marketing as long as the manufacturer followed a long list of requirements, or "special controls," including giving consumers detailed information about risk, genetic counseling, and testing methodology and results.

Special Controls

The FDA is proposing to allow other makers of GHR tests to be exempted from premarket review under certain conditions. If the proposal is made final, GHR test makers would have to get a one-time FDA review to ensure that they meet the agency's requirements, and would then be allowed to market future tests without further review.

The tests would be subject to the special controls, including requirements for assuring accuracy, reliability, and clinical relevance. The FDA will also dictate the type of studies and data needed to demonstrate performance.

The agency is proposing the same exemption from premarket reviews for total 25-hydroxyvitamin D mass spectrometry tests, endoscopic maintenance systems, ultraviolet water purifiers for medical use, and genital vibrators for therapeutic use.

The proposal to "reclassify" these diagnostics and devices is open for public comment until December 31, after which the agency will likely move to make it final.

In the meantime, the FDA also on November 6 gave final approval for exemptions from premarket approval for two diagnostics already on the market.

The Vitamin D 200M Assay for the Topaz System (AB Sciex) will now be able to market new versions without seeking FDA approval first, if it adheres to the special controls. The FDA said in the final order that it was taking this action because it had determined that there would be "a reasonable assurance of safety and effectiveness," and that it "will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens."

The FDA also issued a final order exempting 23andMe's Personal Genome Service Carrier Screening Test for Bloom syndrome from the premarket approval requirements, following through on its stated intention when it approved the diagnostic in 2015.