FDA to streamline path for direct-to-consumer genetic testing

The US Food and Drugs Administration (FDA) is set to further deregulate direct-to-consumer genetic tests, meaning that some will be approved for market without a pre-market review.

Genetic health risk tests (GHRs) provide information about a person's risk for developing certain conditions with genetic risk factors, including Alzheimer's and Parkinson's diseases, by testing DNA from a small saliva sample. Such tests will now get to market quicker and will not be assessed on a product-by-product basis.

Deregulation and growth of this market could bring opportunities for developing genetic tests for other conditions and diseases, providing even more information to consumers which could help them make better informed health and lifestyle choices said the FDA.

'In its consideration of GHR tests, the FDA seeks to strike a balance that provides an efficient pathway to bring these test to consumers, without sacrificing the assurances offered by FDA oversight,' said a statement from the authority.

Prior to 2017 the FDA had banned GHRs assessing personal disease risk, only carrier screening tests for certain inherited genetic diseases were approved. This was due to concerns about the accuracy of GHRs and the risk that consumers could be misled.

'The accelerated development of these innovative DTC genetic risk tests paired with the known safety considerations presents unique challenges to FDA regulation,' said Dr Scott Gottlieb, FDA commissioner. 'These technologies don't fit squarely into our traditional risk-based approach to device regulation.'

However, in April this year a 'de novo classification order', devised to establish the safety and accuracy of GHRs, was used for the first time to approve a GHR test made by the company 23andMe (see BioNews 896). Since then products have been assessed individually according to these standards.

The new regulatory model suggested by the FDA is based on the 'Pre-Cert Pilot Program' designed for digital health technologies. In this model the technology developer rather than a specific product is reviewed. For example, further products developed by 23AndMe can now bypass pre-market review since their technology has already been approved.

The FDA announcement is a 'notice of its intent', and once finalised it means that GHRs will be exempted from pre-market review under certain conditions.