In fall 2015, personal genetic testing company 23andMe launched a new version of its direct-to-consumer test that includes information on consumers’ health. In the following excerpt from an interview with reporter Zoë Corbyn of The Guardian, 23andMe founder Ann Wojckici discussed the company’s efforts to comply with FDA regulations and the ethical implications of genetic testing.
ZC: In October 2015 you relaunched your U.S. test after a run-in with the Food and Drug Administration (FDA) which put the health part in hiatus for two years. How are you regulated in the UK and are you confident you have got the right approvals?
AW: We have an official CE mark to market the test in the UK and in a number of European countries and we are in constant communication with regulators. But I am never as brash and confident as I was five years ago about anything that has to do with regulation. It is a new technology.
ZC: Did the issue with the FDA damage the company?
AW: It was a bump in the road but our intentions were always in the right spot. We are trying to enable low-cost healthcare and prevent rather than treat disease. We have made it affordable and easy to get all this genomic information. That resonates and I think has made it easy to win back trust again.
ZC: Why would people want to do this test and what should they do as a result?
AW: For people who want to be proactive about their health there is a lot of information that we can provide. If you are going to have children I think you have a responsibility to know if you are carrying anything. A lot of people tend to do the testing once they are pregnant.
Read full, original post: ‘Genetic testing is a responsibility if you’re having children’
