You might recognize the name 23andMe as the company that sold home genetic testing kits. Back in 2013, 23andme was all but shut down by the FDA when the FDA ruled that the company could no longer sell its genetic testing kits. In a big turnaround, the FDA has now granted approval to 23andme to sell a home genetic test kit for one specific rare genetic disease.
The disease is called Bloom Syndrome and it is associated with people who are of short stature, have sun sensitivity, and is highlighted by an increased risk of cancers. Those who suffer from the rare condition can develop any type of cancer that is found in the general population, but they often get the cancer earlier than average and are prone to develop multiple types of cancer more rapidly.
This is the first time that the FDA has approved the sale of a direct to the consumer genetic test. FDA officials also noted that kits of this sort will be reclassified to make them exempt from premarket review.
The FDA was concerned back in 2013 that inaccurate results from this sort of tests might lead consumers to get unneeded medical procedures. The tests approved now only test for a single genetic condition. It’s unclear exactly how much those genetic test will cost and when it will be available to consumers.