Mind to Market

Sunday, February 18, 2007

Public Policy on Genetic Tests

A story by Denise Caruso in today's New York Times highlights the wild west nature of genetic testing pitting companies that have invested millions in developing an accurate test against companies "with a couple of genes it ran on 30 samples." She reports that over the last six years there have been "numerous calls by government advisory bodies and expert committees... to develop special rules for labs conducting genetic tests" but none have been made. Last September, the Genetics and Public Policy Center at the Johns Hopkins University filed a citizens' petition with Public Citizen's Health Research Group and Genetic Alliance against the Centers for Medicare and Medicaid Services (CMS) citing the CMS's refusal to address the issue violates the law.

The GPPC comes down strongly on the side of the FDA citing that the Federal Food, Drug and Cosmetic Act (FD&C Act) grants them the authority to regulate genetic tests. According to the GPPC's analysis, the public already has the perception that genetic tests are regulated. The GPPC is advocating three components to ensure the safety and quality of genetic tests:

  1. the laboratories that conduct the tests must have quality control and personnel standards in place to prevent mistakes.

  2. the tests themselves must be valid and reliable - that is, detect genes that are actually related to disease or disease risk accurately over time.

  3. health care providers must understand when to order the tests, how to in interpret them, and what to do with the results.

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