23andMe Receive FDA Approval For Bloom Syndrome Test
23andMe and FDA make significant progress in direct-to-consumer testing.
23andMe are one step closer to a return to the US consumer market. The Food and Drug Administration (FDA) is now willing to consider allowing specific tests. 23andMe’s Personal Genome Service, is not back in the market just yet. But their test for Bloom syndrome has been given the green light by the FDA.
Since 2013’s shut down of 23andMe’s testing service by the FDA, the two organisations have been trying to find a solution. It seems that the FDA’s stance on single tests, might be the reached compromise.
The FDA have to manage a careful position, as they balance the need to give innovation a chance with consumer benefit and safety. This softening in stance, may suggest that they see a strong enough benefit to consumers to allow direct access to genetic information without having to go through a licensed healthcare professional.
23andMe will not be returning Bloom syndrome results at this point. They’re aiming to get back to a more comprehensive offering by completing the regulatory process for additional test reports.
“This is a major milestone for our company and for consumers who want direct access to genetic testing,” said Anne Wojcicki, 23andMe CEO and co-founder. “We have more work to do, but we remain committed to pursuing a regulatory path for additional tests and bringing the health reports back to the US market.”