At the end of 2013, 23andme was ordered to stop selling its DNA testing kit by the Food and Drug Administration. Now, the FDA has granted the company approval to sell a single test for the markers of Bloom Syndrome, a rare genetic disease.
Bloom Syndrome is associated with short stature, sun sensitivity, and increased cancer risk. Sufferers develop any of the cancers found in the general population, but onset is typically earlier and multiple types often develop more rapidly.
The decision by the FDA allowing 23andme to sell the kit is the first time it’s actually approved a “direct-to-consumer” genetic test. The FDA has also said that it will reclassify these kinds of kits, meaning that they will be exempt from premarket review.
Back in 2013, officials were concerned “about the public health consequences of inaccurate results from the… device.” The FDA went on to suggest that false positives or false negatives on the test could lead to startling consequences — like women getting unneeded mastectomies. It turned out that people take such genetic testing pretty seriously!
Thats why the new approval only allows tests for single diseases to be sold. But in a blog post, 23andme writes that it sees this as “an important first step in fulfilling our commitment to return genetic health reports to consumers in the US.” In other words, it’s hoping that this paves the way for approval of its original offer. Only time, and the FDA, will tell. [23andme, FDA via The Verge]
Picture: Shutterstock/isak55