Consumers call for more government oversight of commercial genetic tests

July 7, 2008

With its promises of improved diagnostic and treatment outcomes for arthritis, breast cancer, and other conditions, genetic testing is on a trajectory to becoming a mainstay of the healthcare system. But the field is poorly regulated, prompting calls for more government oversight to help ensure patient privacy and testing accuracy, according to an article scheduled for the July 7 issue of Chemical & Engineering News.

In the article, C&EN Associate Editor Britt E. Erickson points out that genetic tests are now available for some 1,200 different clinical conditions and more tests are in the development pipeline.

With more and more genetic information published on the Internet and the growth of direct-to-consumer genetic testing, there's an urgent need for more government action to help maintain patient privacy while ensuring that test claims are accurate and clinically useful, the article notes.

Changes are already in the works. The Food and Drug Administration (FDA) indicates that it plans to expand oversight of genetic testing in the future. "As the FDA moves to regulate some aspects of this testing area, congressional action will likely be needed to help manage the growth of this emerging health care issue," the article states. At least two states, New York and California, already require genetic-testing companies to prove the validity of their tests.

Source: ACS