FDA Approves 23andMe’s Genetic Test for Personal Disease Risks
– Agency stresses that product labeling should show test not designed to diagnose, determine treatment or say anything about user’s state of health
Wall Street Journal, April 6, 2017 5:47 p.m. ET
Food and Drug Administration approved the first-ever direct-to-consumer genetic testing for people’s personal risk of contracting 10 potentially serious conditions including late-onset Alzheimer’s, Parkinson’s disease, celiac disease and a hereditary blood-clot condition called thrombophilia.
The product is offered by the closely held Silicon Valley genetics-testing company 23andMe Inc., which was initially stymied by the FDA in 2013 when it sought to offer such saliva-analysis tests to the general public. But the company began making more headway by 2015, when it offered consumers a test to tell them if they carried a genetic variant for one of 36 diseases that could be inherited by their children. Those hereditary tests evaluated people for their likelihood of passing on conditions like cystic fibrosis, sickle cell anemia and a disease known as Bloom syndrome.
To date, about two million people have purchased a test from 23andMe, which currently sells an ancestry test for $99 and a combined heredity and ancestry test for $199. With the FDA approval, customers of 23andMe will soon be able to get information about their own risk of 10 diseases, included in that $199 package. The company’s executives, in a phone interview, said that information about four of those diseases—also including a gene variant known as AAT deficiency that can lead to lung or liver disease—will be available by the end of this month, and others will be rolled out later.
The Mountain View, Calif., company stressed that, in all cases, the test “does not describe a person’s overall risk” of developing the disease in question, which can be affected by environmental factors and a person’s lifestyle.
“This is a very significant development,” said Jeffrey N. Gibbs, a medical-device attorney with the Washington, D.C., firm of Hyman, Phelps & McNamara who specializes in FDA matters. Now that this first approval for personal genetic tests has occurred, subsequent products can go through a simplified, and quicker, FDA process that simply requires a company to demonstrate it is substantially equivalent to the test already on the market.
Mr. Gibbs estimates that there are probably dozens of such businesses lining up to offer genetic testing. He noted that the FDA will set controls on the kits’ sale that guide customers as to how serious or how minor a person’s risk is of developing a certain disease. The decision for an individual to gain such genetic-disease risk information is especially thorny in cases like Alzheimer’s and Parkinson’s, where there is little current knowledge about how to prevent the illness.
“Some people really want that information,” said Anne Wojcicki, 23andMe’s chief executive in a phone interview. “They find it empowering. They may want to make diet and exercise changes, or retire earlier, or they may be able to detect symptoms earlier. And then the question is whether we can potentially intervene more effectively by learning the risk sooner.” She called the issue “really a question of personal choice.” Apart from offering the genetic data to customers, the company also mines the data from many of them for information that could potentially lead to new pharmaceuticals. Kathy Hibbs, the company’s chief legal and regulatory officer, said 23andMe has provided the FDA with information demonstrating a high level of precision of the genetic tests. It has conducted “studies to demonstrate that consumers can understand and use this information,” she said. Such context will be provided before purchase and accompanying the test kit, company officials said. Customers will be told that, in some cases, there is limited or no treatment and that the disease-risk information may be upsetting to them, said Ms. Hibbs.
The company, named for the 23 pairs of chromosomes in a human cell, hasn’t always had such a happy relationship with the FDA. In November 2013, the FDA ordered it to stop marketing its mail-order kit, referring to a risk that false results could result in unnecessary medical procedures including breast-cancer surgery. It wrote that false results on people’s response to the blood-thinner drug warfarin could lead to clotting or bleeding and a risk of injury or death.
In a letter to the company Thursday, the FDA said product labeling should show that the test “is not intended to diagnose a disease, determine medical treatment or tell the user anything about their current state of health.”
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