After forcing 23andMe to pull its personal genome testing service from the market in 2013, the FDA has given marketing approval for the company’s Bloom syndrome carrier test, a direct-to-consumer genetic test to identify the gene variant, which can be passed on to offspring.
The agency also announced that it will classify carrier screening tests as class II, and intends to exempt the screening tests from premarket review. The decision, which lessens the regulatory burden for such screening tests, will be open for public comment for a 30-day period.
“The FDA believes that in many circumstances it is not necessary for consumers to go through a licensed practitioner to have direct access to their personal genetic information. Today’s authorization and accompanying classification, along with FDA’s intent to exempt these devices from FDA premarket review, supports innovation and will ultimately benefit consumers,” said Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, in a press release.
The move is one step in a positive direction for the relationship between the FDA and 23andMe, which was founded by Anne Wojcicki, the estranged wife of Google co-founder Sergey Brin. The revolutionary company came under fire from the FDA in 2013 after discussions on how to regulate the product fell apart.
The original $99 genetic test, which required users to mail in a sample of their saliva for DNA, was considered by the FDA to be a medical device and the service to be a medical intervention, therefore constituting FDA regulation. The FDA maintained that 23andMe had failed to gain marketing clearance or approval which would have ensured that their test was accurate, reliable, and clinically meaningful.
In its approval of the Bloom Syndrome screening test, the FDA is requiring that test results be conveyed in a way that consumers can understand. If sold over the counter, it is requiring 23andMe to provide information to consumers about how to access a board-certified clinical molecular geneticist to facilitate pre- or post-test counseling.
In order to test the screening tool’s accuracy, 23andMe conducted two studies to determine accuracy with 123 and 105 samples, respectively, a third test to evaluate usability, and a fourth user study to test the ease of use of the instructions and results.
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