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Washington, DC - October 28, 2008 - The National Human Genome Research Institute has awarded a two-year grant totaling $589,318 to the Genetics and Public Policy Center at Johns Hopkins University to study the rapidly growing field of direct-to-consumer (DTC) genetic testing. The Center will use the grant to examine issues raised by companies offering tests and test interpretation directly to consumers rather than through the traditional model of health care provider-offered genetic tests, explained principal investigator Gail Javitt. The NHGRI award complements and extends support for a genetic testing quality initiative at the Center funded by The Pew Charitable Trusts.

“Ensuring that the public has information adequate to making informed choices about genetic testing is prerequisite to realizing the public health benefits that have been promised from genetic medicine,” said Javitt, who also is the Center’s law and policy director. “The key to understanding the dramatic growth in DTC genetic testing is to understand who is ordering these tests, how they use that information, and how the ordering and testing process is regulated at the federal and state levels.”

Right now, she explains, we know very little about the DTC landscape or how it will affect health and health care in the future. Genetic tests for more than 1,300 diseases or conditions are available clinically, and the number is growing rapidly. Theoretically, almost any genetic test for these diseases could be offered directly to consumers, and more than 30 companies already have entered the DTC genetic testing market, including major players Navigenics, 23andme, and deCODE.

The study will analyze the current regulatory framework governing the advertising and selling of genetic tests directly to consumers, evaluate the validity of marketing claims for specific tests by comparing those claims to the scientific literature, and assess attitudes and experiences of consumers who have used DTC testing services.

“There is a lot of hype and a lot of angst about how personal genome testing will play out in health care,” Javitt noted. “What’s missing are hard facts about this industry and its consumers, and what the public’s motivations for, and experiences with, these tests have been.”

The project also taps the Center’s rich expertise in identifying public attitudes and opinions about genetic testing and genetic research, most recently demonstrated in a two-year study for NIH of public concerns about participating in long-term, large-cohort genetic studies.

“Consumer interest clearly will drive the future market for DTC genetic testing,” says Javitt. “But we don’t know what consumer expectations are, or whether they are met by genetic tests currently available DTC.”

The project began Oct. 1. – Rick Borchelt

Issue brief – Direct-to-consumer genetic testing: empowering or endangering the public?

Chart – Survey of Direct-to-Consumer Testing Statutes and

Chart – Direct-to-Consumer Genetic Testing Companies


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