By Diane Allingham-Hawkins, PhD, FCCMG, FACMG, Senior Director, Genetic Test Evaluation Program and Technical Editing
Are you concerned about the relative lack of regulatory oversight of genetic testing in the United States? We are. In the April 1, 2013, issue of Managed Healthcare Executive magazine Dr. Wini Hayes, CEO of Hayes, Inc., and I voiced our concerns and summarized some of the ongoing efforts by the Food and Drug Administration (FDA) to monitor laboratory-developed tests and tests that are marketed directly to consumers. You can read the complete article here.
As we stated in the article, with any type of genetic or molecular testing, but especially with those marketed directly to consumers, a level of regulatory oversight is required to ensure that a test does what it says it will do and predicts what it says it will predict. The results of these tests are often intended to specifically guide therapy and to promote use of novel technologies as clinical diagnostics. Without an appropriate level of oversight by the FDA or other organization, payers, providers, and consumers need guidance to understand the scientific evidence surrounding these tests and to determine when and for whom they should be used.
Patients should not have to pay the price when a lack of regulatory oversight enables companies to rush genetic tests to market without proper evidence of their analytical validity, clinical validity, and clinical utility. Nor should payers be put into a position to reimburse for a test that may do nothing for the patient or, worse, do more harm than good.
Would you like to learn more about genetic testing? Here are some resources to get you started:
- American College of Medical Genetics and Genomics (ACMG). Position Statement on Gene Patents and Accessibility of Gene Testing.
- Association for Molecular Pathology. Test Directory
- DTC Advisory Meeting of the FDA’s Molecular and Clinical Genetics Panel.
- FDATrack Dashboard for Personalized Medicine.
- Hayes, Inc.: Gene Patenting in the United States—Where Have We Been, Where Are We Going?