23andMe relaunches direct-to-consumer tests for genetic disease

23andMe is relaunching its direct-to-consumer genetic tests after gaining government approval for a more limited array of tests to inform you about your risk of passing on a genetic disease.

In 2013, the company was banned from selling a genetic test that provided customers with information about their risk of developing 254 conditions, including breast cancer, Alzheimer’s and heart disease. The US Food and Drug Administration (FDA) said the company had not proved that it had clinically validated their tests for their intended uses.

Nearly two years on, 23andMe has announced that it will resume selling a genetic health testing kit, which is based on a sample of saliva, although it will include tests for fewer diseases, all of which have been FDA approved.

The company has also redesigned its website to make personalised genetic information easier to understand and increased the price of the test from $99 to $199.

“We’ve worked with the FDA for nearly two years to establish a regulatory path for direct-to-consumer genetic testing,” said Anne Wojcicki, CEO of 23andMe, in a statement. “We are a better company with a better product as a result of our work with the FDA.”

23andMe will provide customers with data based on “carrier information” about genetic mutations that could lead to disease in offspring. The kit includes tests for 36 diseases, such as sickle cell anaemia and cystic fibrosis.

“The new product focuses on carrier mutations, or specific gene changes, known to cause health issues when children receive the mutations from both parents,” says Brian Zikmund-Fisher at the University of Michigan School of Public Health, Ann Arbor. “Issues like behaviour and environment don’t generally matter for these diseases.