The experts GAO consulted felt the tests were promising for the future, but that "consumers should not rely on any of the results at this time" as the different prediction of risk shows difficulty in interpreting the tests.

GAO also found several "egregious" examples of deceptive marketing in the tests, including claims that a consumer's DNA could be used to create personalized supplements to cure diseases; that two companies stated their supplements could "repair damaged DNA;" and two companies claimed they could predict in which sports children would excel based on DNA analysis.


Government and experts weigh in

Dr. Jeff Shuren, director for the FDA's Center for Devices and Radiological Health testified about the laws covering the tests and the history of regulating such tests. Shuren said that marketing genetic tests directly to consumers "can increase the risk [consequences] of a test because a patient may make a decision that adversely affects their health, such as stopping or changing the dose of a medication or continuing an unhealthy lifestyle, without the intervention of a learned intermediary." He further said the FDA is working toward a reasonable and fair approach to regulation to give patients and doctors confidence in the tests and facilitate progress in personalized medicine.

Dr. James P. Evans, editor-in-chief of Genetics in Medicine and Bryson professor of genetics and medicine at the University of North Carolina at Chapel Hill explained in his testimony that he felt the public may be soon be in an era "in which much, if not most, genetic testing could be done outside the confines of the traditional doctor's office or medical setting." Individualized medicine and access to the information contained in one's own genome is important, Evans stated--but also of critical importance is that any such information received is of high quality and that the "purveyors of such testing comport with reality."

Right now, Evans said the most egregious problem, as well as the most remediable, is the gap between claims made by the providers of such services and the value of the information actually given to consumers. He concluded by saying that the interests of companies and the public are actually fully aligned, since both interests will thrive only when tests and the claims made for those tests are trusted.

"I believe that the public deserves access to the information contained in their own genomes," he said. "But they also deserve an honest accounting of what such information means and the assurance that it is derived in a manner that ensures quality, reliability and confidentiality."

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