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Just when consumers were getting ready to wield more decision-making powers by using personalized DNA analysis to determine their risk for chronic diseases, federal regulators have decided to put the kibosh on it.

In a letter to 23andMe, a Google-backed consumer genetic company, the U.S. Food and Drug Administration (FDA) issued a stern warning to cease marketing these personal genome services to consumers unless the company can provide satisfactory evidence that the results of the DNA analysis are reliable and won’t jeopardize consumer health. Following the FDA’s directive, 23andMe has suspended health-related genetic tests and only offers consumers ancestry-related genetic tests and raw genetic data, without 23andMe’s interpretation.

The FDA’s action underscores concerns from critics that direct-to-consumer genetic tests, which while informative, may not provide the full context to consumers on what those results mean or what action should they take. While there are many other issues and debates swirling around the 23andMe subject, for healthcare communicators, it comes down to this: how can we ensure the best communication possible during a consumer’s experience with an at-home medical test? What should consumers do once they get their test results? Should they be sharing them with their doctors? Should at-home test kits include a guide or recommendations to help consumers interpret test results or act on next steps?

As my colleague Jeanine O’Kane notes in her article titled “The Positive Outlook at At-Home Medical Tests” (page 8), with at-home medical tests, consumer education, strong healthcare partnerships and patient support are part of the journey to correct usage, accurate results and product credibility. And because at-home tests rely solely on the consumer getting it right, manufacturers must be extra diligent in communicating what the product is for and how to use it. We need to educate consumers about the benefit and risks, as well as the importance of interpreting the results of such tests using guidance from a medical professional or other trusted sources.

Consumers having more access to information and increased responsibility for their own health is the new reality. Manufacturers must determine if their communications will make this new reality positive or negative.

 

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