NEW YORK — Inside the labs at 23andMe, technicians are processing thousands of saliva samples from people who used the take home kit to get genetic information about their ancestry or health.
“The test that we offer is a great way for those people to get access to the information directly without having to get a prescription,” said Emily Drabant Conley.
For the first time ever, the FDA is allowing the company to test for BRCA mutations.
“They are applicable primarily to people of Ashkenazi Jewish ancestry, so that’s an important limitation of the test.”
23andMe only tests for three possible BRCA mutations that are only seen in a very small percentage of the population- something Professor David Magnus worries will confuse at home users.
“People will misunderstand and believe that because they test negatively, that is, they don’t test positive for any of the three BRCA genes that are being tested by the company, that that means they have a clean bill of health.”
He pointed out that someone could still have another one of the thousands of BRCA genes that aren’t covered by the take home kit.
“For some people who might be getting this test, it might be hard for people to interpret and understand those results.”
Company representatives say it’s something they’ve worked through with the FDA.
“23andMe has had to show that people could understand this information receiving it directly rather than receiving it through a health care provider.”