The Limitations of DNA Test Kits for Americans

Genealogists take DNA tests for two reasons. One is because the results could reveal relatives that they were unaware of. The other reason has to do with health. Some DNA tests can reveal whether or not a person has genes that might increase the risk for certain diseases. However, there is a limitation on DNA test kits for Americans – one that isn’t placed upon genealogists in other countries.

Peter Whoriskey wrote an article titled “Wondering if you have the gene for Alzheimer’s? You may have to leave the country to find out.” It was published in the Washington Post in December of 2015.

In it, he points out that genealogists who use direct-to-consumer DNA testing kits from 23andMe in Canada, the United Kingdom, or Europe, can obtain much more health related information from the results of a DNA kit than can Americans. The reason why has to do with an issue between 23andMe and the United States Food and Drug Administration (FDA).

In the United Kingdom, health officials only require 23andMe to affirm that the “device”, the plastic tube that is used to collect saliva, is safe. The DNA test itself is not regulated. Officials at Health Canada also do not regulate the 23andMe DNA test.

In November of 2013, the FDA sent a warning to 23andMe about their DNA testing kits. In short, the FDA felt that the genetic information revealed by the DNA test could have dangerous results. There was potential that the test would reveal a false positive. The user wouldn’t know that, and might seek out preventative measures for a disease risk that they didn’t actually have.

The FDA was also concerned because people who used 23andMe’s DNA testing kits were receiving results without having a doctor review them. As such, the FDA required 23andMe to stop selling their DNA test kits (or, to sell the kit with only the genealogy related results).

Later, after changes had been made that satisfied the FDA, 23andMe was able to once again sell DNA test kits to American consumers that included genetic information. The test now can tell you about genes for hair color, lactose intolerance, and, of course, ancestry. But, the test won’t tell American consumers if their genes indicate a higher risk for breast cancer, celiac disease, Alzheimer’s or Parkinson’s diseases.

No such limitations are placed upon the DNA test kits from 23andMe that are sold outside of the United States. It is an interesting situation to think about. American genealogists cannot get the same information from a 23andMe DNA test kit that genealogists outside of the country can – due to FDA regulations. People may see this as a safe precaution, or might feel that it is restricting.

Image by Boston Public Library on Flickr.

Related Articles at FamilyTree.com:

* The FDA Has Ordered 23andMe To Stop Marketing Its Personal Genome Service

* 23andMe Resumes Genetic Testing

* Genetic Studies Provide Possibilities in Cancer Treatment