Informed Health Decision-Making through a Registry for Genetic Tests

What ELSI is new (article)This commentary in the Genomics Law Report’s ongoing series What ELSI is New? is contributed by Sharon F. Terry, Genetic Alliance.

Diagnostic testing is one of the first clinical fruits of genomics, and certainly the leading edge of personalized medicine. As such, the most critical ethical, legal and social issue that must be addressed by the field of genomics and personalized medicine is oversight of these tests. We focus here on one aspect of oversight: a registry for genetic tests to allow providers and consumers to make informed choices.

A registry should be developed and maintained that includes the name of the laboratory performing a specific test, the name of the laboratory or manufacturer that developed the test, and information to support claims about the analytical validity and clinical validity of that specific test or test method. Submission of information to this registry should be mandatory for all advanced diagnostic assays. This registry should be created and maintained by NIH since it has enormous capacity related to genomic informatics.

Such a registry would provide a framework for transparency to allow the field to contribute to clinical medicine in a meaningful way. Individuals, their providers and payers, would have the information they need to make informed decisions. We desire a transparent regulatory system. As Javitt et al state in a recent paper, the Secretary of HHS has “the explicit authority under both the FD&C Act and CLIA to develop a genetic test registry in order to protect public health.”1  Oversight of genetic tests requires a modern 21st century system involving FDA, CLIA, and many stakeholders, this is a necessary first step.

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Javitt G, Katsanis S, Scott J, Hudson K. Developing the Blueprint for a Genetic Testing Registry. Public Health Genomics. 2009 Jun 29.