23andMe is a company that offers a DNA test kit. Genealogists can use it to learn more about their heritage. Everyone can use it to learn about their health. 23AndMe is among the groups asking for the FDA to approve their test kits.
The ability for a consumer to purchase a home DNA test kit, to send off a sample, and to learn more about the information that is hidden in their genes, is a new concept. It’s only been possible for a few years. Companies like 23andMe, DeCODE, Navigenics, Ancestry.com, and more sell some form of home DNA testing kits to consumers.
Previous to this, the only way to learn more about your genetics was if your doctor suggested it. The idea here would be to determine if a person had the genetics that indicate a higher risk for a certain disease. Or, it could be to see if an unborn baby had certain genetically heritable diseases. DNA tests weren’t used for genealogy research purposes, except for paternity tests.
In 2011, some questions were asked about the reliability of home DNA test kits. There was concern that the results could be incorrect. Imagine getting results that said you had the genetics for a lethal disease, when, in reality, you don’t. Some wanted doctors to be involved, to talk people through appropriate health care based on the results of the DNA test.
23andME announced that they have submitted their first wrong of 510(k) documentation to the Food and Drug Administration (FDA). This is one more step in the work that 23andMe has done with the FDA to improve the FDA’s regulatory approach to direct-to-consumer genetic testing. The 23andMe company says that its application is complete and comprehensive.
What does this mean for genealogists? You can still purchase a DNA test kit from 23andMe if you want to. At the time that I am writing this blog, it looks like they are on sale for $299.00. (instead of the usual $399.00). If you have already done so, and are currently using the services at 23andMe, you can continue to do so. You can still learn more about what your DNA says about your ancestry and health.
For now, nothing changes. At some point in the future, the FDA will make some sort of decision about whatever it has learned from the application sent to it by 23andMe. We will eventually hear about it. Perhaps, some changes will be made as a result, but, for now, everything stays the same as it currently is.
Image by Kari Sullivan on Flickr