The Food and Drug Administration finally gave 23andMe a long sought-after green light today to sell to consumers genetic tests and their accompanying health risk reports for up to 10 diseases, including late-onset Alzheimer’s and Parkinson’s.
In November 2013, the FDA put a moratorium on 23andMe’s ability to provide any health information associated with its personal genome testing. Then a sliver of hope opened up in October 2015, when the FDA allowed the company to provide health and carrier status for those who might pass on a rare genetic disease. Shortly before that, and as sort of a trial run before opening up the floodgates, 23andMe was able to test for a genetic carrier disease called Bloom Syndrome, a rare recessive gene disorder characterized by shorter height and a predisposition to develop cancer.
This morning the FDA announced it would allow 23andMe to also provide consumers with information on 10 diseases, including the following:
- Parkinson’s disease, a nervous system disorder impacting movement;
- Late-onset Alzheimer’s disease, a progressive brain disorder that destroys memory and thinking skills;
- Celiac disease, a disorder resulting in the inability to digest gluten;
- Alpha-1 antitrypsin deficiency, a disorder that raises the risk of lung and liver disease;
- Early-onset primary dystonia, a movement disorder involving involuntary muscle contractions and other uncontrolled movements;
- Factor XI deficiency, a blood-clotting disorder;
- Gaucher disease type 1, an organ and tissue disorder;
- Glucose-6-Phosphate Dehydrogenase deficiency, also known as G6PD, a red blood cell condition;
- Hereditary hemochromatosis, an iron overload disorder; and
- Hereditary thrombophilia, a blood-clot disorder.
“Consumers can now have direct access to certain genetic risk information,” the FDA’s director of the Center for Devices and Radiological Health Jeffrey Shuren said in a statement. “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.”
Showing you have an increased risk for a particular disease doesn’t mean you will get the disease, as Shuren said, but it is a point which led the FDA to ban 23andMe from offering this type of information previously. However, consumers may want to know if they need to take steps to prevent certain genetic diseases, such as breast cancer, and that is what these genetic health risk (GHR) tests intend to show. You may recall Angelina Jolie famously had removed both her breasts to ensure she never got the disease after discovering she, like her mother, had the BRCA gene, indicating she could develop breast cancer one day.
This announcement makes 23andMe the only company allowed to give out genetic disease reports to consumers (sans doctor’s prescription). Those who are already 23andMe customers in the U.S. will get these reports when they roll out later this month but it remains to be seen for other countries, due to regulations.
Information will be rolled out over time, according to a 23andMe spokesperson, but will start this month with Late-Onset Alzheimer’s Disease, Parkinson’s Disease, Hereditary Thrombophilia, Alpha-1 Antitrypsin Deficiency and a new carrier status report for Gaucher’s Disease. Other tests will soon follow, 23andMe tells TechCrunch.
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