FDA advisory panel weighs genetic tests

A FDA advisory panel is addressing the risks and benefits of direct-to-consumer genetic tests, which are sold directly to consumers who can learn about potential health risks via the Web or by mail, this week.

A FDA advisory panel is addressing the risks and benefits of direct-to-consumer genetic tests, which are sold directly to consumers who can learn about potential health risks via the Web or by mail, this week.

On the first day of the hearing, the Los Angeles Times reported the panel recommended genetic tests that are marketed directly to consumers should only be allowed under the supervision of a physician.

The issue of genetic tests, according to the FDA, is whether consumers understand the limitations of the tests and if they may choose to move forward with treatment (or without) before consulting a physician.

The federal agency may set standards for the genetic tests similar to the rules in place for prescription-only genetic tests or home pregnancy tests.

The companies that make genetic tests, such as 23andMe and Illumina, will argue the benefits of selling tests directly to consumers. According to The Associated Press, 23andMe is focusing on the need for regulations to be flexible as the field of genetics is changing.

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