FDA OKs First Direct-to-Consumer Genetic Risk Tests

Disclosures

April 06, 2017

In the latest step toward personalized medicine, the US Food and Drug Administration (FDA) today approved the first direct-to-consumer (DTC) genetic tests that provide information on a person's risk of developing a disease.

The tests in question, offered by 23andME, provide information on an individual's genetic predisposition to late-onset Alzheimer's disease, Parkinson's disease, celiac disease, and seven other conditions. The FDA cautions that test results by themselves do not provide a complete picture of risk because environmental and lifestyle factors also help determine whether an individual develops a particular condition.

However, results from 23andMe's Personal Genome Service Genetic Health Risk (GHR) tests may help individuals make appropriate lifestyle choices and prove useful in discussions with healthcare providers, according to the agency.

The other seven GHR tests approved by the FDA today are for:

  • α1-Antitrypsin deficiency;

  • Early-onset primary dystonia;

  • Factor XI deficiency;

  • Gaucher disease type 1;

  • Glucose-6-phosphate dehydrogenase deficiency, also known as G6PD;

  • Hereditary hemochromatosis; and

  • Hereditary thrombophilia.

The FDA approved the first DTC genetic test — again, from 23andMe — in February 2015, but the test was not designed to assess risk for disease as a GHR test does. That earlier test identified a person's carrier status for Bloom syndrome, an autosomal recessive condition characterized by stunted growth, sunlight sensitivity, and an increased risk for infections and cancer. Later that year, 23andMe received approval  to market a full line of carrier status tests for other autosomal recessive conditions, such as cystic fibrosis, sickle cell anemia, and Tay-Sachs disease.

More information on today's announcement is available on the FDA website.

Follow Robert Lowes on Twitter @LowesRobert

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