Currently, only home tests that make medical claims are regulated by the agency.
Last year, Pathway Genomics announced that it would start selling tests (in general, the test can cost from $400 to $2,000) at Walgreens stores, which are ubiquitous in the United States. Walgreens reversed its decision, however, after the FDA raised questions about the supplier.
Before drafting regulations for the direct-to-consumer tests, the FDA had asked its advisers and test manufacturers for input in a variety of areas, including the reliability of the tests; the possibilities for misuse; the likelihood -- and consequences -- of misunderstood results; and how a lack of counseling might affect people who receive disturbing results.
For the tests, consumers can take a sample of their saliva or blood, for example, and send it to a clinical laboratory for analysis without guidance or oversight from a medical professional. Patients must initiate any medical follow-up or counseling on their own.
Because people might make medical decisions based on the test results, the FDA will probably set standards to minimize the chance of misuse or misinterpretation of test results, similar to standards governing prescription-only genetic tests or home tests such as pregnancy tests.
Other considerations will include how to categorize the different types of home genetic tests. Three possibilities, the FDA said, include: tests that screen for carriers of a disorder that can be inherited; tests that predict risk for a disorder, such as ovarian cancer, in people with no symptoms; and tests claiming to predict how someone will respond to a particular drug or medical treatment.
Test makers defend their products, but test accuracy is a key concern of skeptical medical professionals. A recent undercover study of 15 direct-to-consumer genetic tests by the U.S. Government Accountability Office found
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