FDA approves the first disease screening by gene testing company

Testing companies have long promised consumer genetic testing for a wide range of health conditions, but to date much of the testing has been seen by many scientists as speculative. Now in a reversal, the Food and Drug Administration (FDA) has given the green light to one test offered by a California gene testing firm.

Nearly two years ago, the FDA ordered the gene testing firm 23andMe to halt its direct-to-consumer sales of screenings it was offering for health issues, including tests that purported to show clients whether they have an increased risk of conditions ranging from Alzheimer’s disease to breast cancer, to addiction and dozens more. At the time, the company ceased its sales of such tests in the U.S., according to Fast Company.

But the company continued selling the screenings in other countries, and in the U.S. consumers could still receive ancestry testing from 23andMe.

Now FDA has for the first time approved a 23andMe genetic test for a disease. The company may sell consumers a kit they can use to test for Bloom Syndrome, a rare disorder linked with an increased risk of cancer. In addition, 23andMe can offer consumers test kits for some similar diseases, like cystic fibrosis and Tay-Sachs, that are linked with each parent having copies of the abnormal genes that are linked with the disease.

As a condition for allowing the sales for these health conditions, FDA is requiring 23andMe to educate consumers about the purposes and value of such genetic tests, despite the obvious conflicts of interest. The agency’s decision does not clear the company to offer the wide range of health screenings it previously marketed to consumers.

The company’s co-founder Anne Wojcicki, who was formerly married to Google co-founder Sergey Brin, is a carrier of Bloom Syndrome.