- Lydia Ramsey/Business Insider
23andMe can once again tell you whether you have an increased risk of developing certain diseases.
In November 2013, the US Food and Drug Administration barred 23andMe from sending any of that data related to health to customers because of concerns that the company was misrepresenting genetic tests as medical advice.
When the test relaunched in 2015, 23andMe was able to provide health reports showing whether a person carried a variant for a genetic disease that could be passed down to his or her child, along with wellness reports providing information about caffeine consumption and lactose intolerance.
On Thursday, the FDA identified 10 risk tests that 23andMe could include:
- Parkinson’s disease Late-onset Alzheimer’s disease Celiac disease Alpha-1 antitrypsin deficiency Early-onset primary dystonia Factor XI deficiency Gaucher disease type 1 Glucose-6-Phosphate Dehydrogenase deficiency Hereditary hemochromatosis Hereditary thrombophilia
“Consumers can now have direct access to certain genetic risk information,” Dr. Jeffrey Shuren, the FDA’s director of the Center for Devices and Radiological Health, said in a news release. “But it is important that people understand that genetic risk is just one piece of the bigger puzzle – it does not mean they will or won’t ultimately develop a disease.”
- Hollis Johnson
A 23andMe spokesman said a first batch of tests will be available later this month. And beyond the 10 tests the FDA allowed Thursday, other tests for genetic health risks would be exempt from needing FDA review, so in the future the company could develop tests for other blood-clotting disorders or age-related macular degeneration.
Kathy Hibbs, chief legal and regulatory officer at 23andMe told Business Insider that when the Alzheimer’s disease and Parkinson’s disease tests do go live, users will have to opt-in to receiving the reports. Because there are limited treatments for both neurodegenerative conditions, the hope is to make it clear that there’s additional information to consider before receiving the results. Users can opt out of receiving the reports both during the ordering process and once they receive the results.
An increased risk doesn’t mean a person will necessarily get the disease – just that the chances are higher. For example, in a cancer-screening genetics test – which is not among the 10 that 23andMe is allowed to market – the risk of getting breast cancer increases to as high as 65% from 7% when a person has the BRCA1 or BRCA2 gene mutations. The FDA said in the release that this type of test counted functions as a diagnostic test, so it and others like it weren’t included as part of the market authorization. Hibbs said that doesn’t mean 23andMe can’t one day try to get such tests approved.
“It doesn’t shut the door on our ability to seek it, but it does make the distinction,” Hibbs said.
Knowing you have one of these genetic tweaks, then, could help you make more proactive decisions, like getting more frequent cancer screenings or eating healthier.