23andMe receives FDA approval to sell genetic tests without prescriptions

On April 7, 2017 the Food and Drug Administration (FDA) granted approval to the company “23andMe” to sell genetic screening tests directly to the public.

Anne Wojcicki is the CEO of the company, and married to Sergy Brin, the co-founder of Google. Thus 23andMe is a subsidiary of Google specialized in sequencing the human genome.

23andMe is the first and only company authorized by the FDA to provide personal genetic health risk reports without a prescription or medical advice.

Simply by mailing a saliva sample, and paying $100, clients can receive information on their risk for 10 different conditions: Parkinson’s, Alzheimer’s, Celiac and Gaucher diseases, hereditary conditions of Hemochromatosis and Thrombophilia, deficiencies in Alpha-1 Antitrypsin, Factor XI and Glucose-6-phosphate Dehydrogenase (G6PD), and Muscular Dystonia.

This is a worrisome decision because even if the tests are not new, the approval will give clients weighty information directly, without any counseling from a medical professional. And the tests are not foolproof: the FDA noted that there is always a risk of false positives or false negatives. Analyzing the results is a complex task; and could be misinterpreted.

The 23andMe blog specifies: « Not everyone with a risk variant will develop specific health conditions. And for most of these conditions, not having a genetic variant does not eliminate the risk of the health condition.”

For example, the relationship between Alzheimer’s disease and the APOE variant (measured by the genetic test) “is complex and not fully understood” declared Dr. Mary Ganguli, a professor of geriatric psychiatry at the University of Pittsburgh. “For one thing, the association is weaker in African-Americans than in whites. For another, the risk fades with age; if you make it beyond age 80 without developing Alzheimer’s; you’re no longer at elevated risk, even if you have the variant.”

The FDA approval comes only a few years after the controversy erupted between the Agency and the California firm selling genetic tests. In 2013, the FDA filed a complaint against 23andMe for false advertising, who claimed their $99 kit could detect over 240 conditions and characteristics specific for recessive genetic diseases. The company pulled the genetic tests off the market, preferring to give their clients raw genetic data.

The FDA’s “turnaround” might seem surprising. However, Dr Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health cautioned clients “to not interpret their test results as to mean they will or won’t ultimately develop a particular disease”. In a press release he stated: “It is important that people understand that genetic risk is just one piece of the bigger puzzle”.


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