23andMe ran into trouble with the FDA over its DNA testing, which included results of a medical nature — info about disease risks and such. It ultimately had to shut that part of its service down, but another company may take over in its place. Ancestry.com is in talks with the FDA about launching a DNA testing kit that will be used to provide possible health information about a person — details about things like one’s reaction to medication and more based on their genetic details.
Ancestry’s CEO Tim Sullivan revealed some information about the company’s efforts in a statement to The Verge, saying the company is in the “very early stages of a conversation with the FDA. We think it’s totally appropriate that the FDA has stepped in to pretty aggressively regulate direct-to-consumer genetic tests — and we’re just starting from that perspective, and trying to work very closely with them.”
Ancestry presently offers a DNA testing service, which costs $99, but it focuses on ancestry, not health — meaning you can use it to find out about where you’re from, but not things related to your personal health. Expanding the service to include health details will require permission from the FDA, and getting such, by all accounts, will not be simple.
23andMe did ultimately win a small bit of favor from the FDA, which granted it permission to offer a DNA kit for testing…but only for one specific disease, Bloom Syndrome.
The FDA’s decision to nix a wider array of health-based genetic testing prompted a lot of criticism, as well as multiple stories of individuals who had hard to decipher medical conditions brought to light through such testing. On the other hand, the tests have been criticized as less-than-accurate, prompting customers to seek medical treatment against possible diseases they may not actually be at risk for.
SOURCE: The Verge