Yesterday I received this announcement from 23andMe:
I am happy to announce that the U.S. Food and Drug Administration (FDA) granted 23andMe authorization to market ten direct-to-consumer, genetic health risk reports. This new category of health reports will provide customers with information about genetic variants that could increase their risk for certain diseases.
The authorization includes reports on Late-Onset Alzheimer’s Disease, Parkinson’s Disease, Celiac Disease and Hereditary Thrombophilia as well as six additional conditions. To learn more about these reports and the additional reports covered in the authorization, you can refer to the FDA’s press release or our blog.
I am proud to say we are the first and only company to receive FDA authorization to market genetic health risk reports without a prescription. It’s a defining moment – giving individuals direct access to more information about how their DNA could impact their health.
The first set of new genetic health risk reports to be released in the U.S. will include Late-Onset Alzheimer’s Disease, Parkinson’s Disease, Hereditary Thrombophilia, Alpha-1 Antitrypsin Deficiency, and a new carrier status report for Gaucher’s Disease. These will be available by the end of April with additional reports to follow. Look for an email in the next few weeks about your eligibility to receive these reports.
CEO and Co-Founder
From the press release, the health conditions are as follows:
- “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.”
I am most intrigued by the late-onset Alzheimer’s results. Intriguing development, and a reason to consider 23andMe if you are interested in the results of these tests.