The U.S. Food and Drug Administration has given 23andMe clearance to begin selling kits for the genetic testing of Bloom Syndrome.
This is a rare recessive gene disorder that is characterized by shorter height and a predisposition to develop cancer. Parents of children with Bloom Syndrome don’t exhibit any symptoms of the disorder.
23andMe’s direct-to-consumer genetic test allows someone to see if they have a specific gene variant for Bloom Syndrome and helps parents know if they could potentially pass on the gene that would cause their children to have the disorder.
This is a significant ruling from the FDA. 23andMe had been ordered to stop selling at-home testing kits after not meeting the necessary FDA approval to do so back in 2013. The kits tested for 254 different kinds of disease markers. The FDA had classified these kits as medical devices for that reason and determined that it required regulatory approval before being sold to the public. This is the first time the FDA has approved this sort of test without a doctor’s approval.
It gives 23andMe a regulatory framework for future submissions— Anne Wojcicki
The FDA has classified the Bloom Syndrome carrier screening tests as class II, meaning the kits have special controls in place for direct-to-consumer marketing. The kits are also intended for exemption from FDA pre-market reviews, according to the FDA.
This is a rare recessive gene disorder that is characterized by shorter height and a predisposition to develop cancer. Parents of children with Bloom Syndrome don’t exhibit any symptoms of the disorder.
23andMe’s direct-to-consumer genetic test allows someone to see if they have a specific gene variant for Bloom Syndrome and helps parents know if they could potentially pass on the gene that would cause their children to have the disorder.
This is a significant ruling from the FDA. 23andMe had been ordered to stop selling at-home testing kits after not meeting the necessary FDA approval to do so back in 2013. The kits tested for 254 different kinds of disease markers. The FDA had classified these kits as medical devices for that reason and determined that it required regulatory approval before being sold to the public. This is the first time the FDA has approved this sort of test without a doctor’s approval.
It gives 23andMe a regulatory framework for future submissions— Anne Wojcicki
The FDA has classified the Bloom Syndrome carrier screening tests as class II, meaning the kits have special controls in place for direct-to-consumer marketing. The kits are also intended for exemption from FDA pre-market reviews, according to the FDA.
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