Making Participation Mandatory
The testing landscape currently includes a wide range of institutions and companies offering testing services, with a broad range of interests. This diversity results in a spectrum of quality and intentions that include standard-setting good actors, as well as bad actors who ultimately harm the system.
For this reason, the GTR is only a first step; next, the registry should be made mandatory. A system that includes a mandatory registry and enables informed decision-making has the potential to create incentives to increase quality and access for genetic testing through mechanisms such as adverse event reporting to track the harms of testing, and to help ensure high-quality tests.
The National Center for Biotechnology Information (NCBI), part of the National Library of Medicine at NIH, will be responsible for developing the registry. Therefore, GTR genetic-test data will be integrated with other NIH/NCBI databases to facilitate connections for researchers. The registry should also include education regarding basic genetics and the testing process; professional society recommendations and guidelines; information for patients and providers on risk or diagnosis; and referral networks for specialists, researchers, and disease-specific organizations.
Such a layered, linked, and integrated registry would be able to maximize its own potential benefits and facilitate its integration into the genetic testing and healthcare systems. It would provide a gateway for access to services and information, as well as facilitate important connections for those who receive a diagnosis through the testing process.
Ultimately, a mandatory genetic testing registry will improve public health by enabling a forward-looking oversight system that is flexible and nuanced. It would undergird a transformed system that is open, transparent, and coordinated with all stakeholders and agencies, and one that balances safety, innovation, ethical and social issues, viability, and the risks and benefits of improved health.
A registry that includes all tests across the risk continuum and comprehensive standardized information in a format appropriate for the public would enable truly informed decision making by all players.
On occasion, Genetic Alliance is challenged by laboratory directors and organizations that advocate for their interests. The challenge usually comes in the form of this question: “Won’t GTR be onerous for laboratories, creating undue burden for reporting, and therefore, increasing the costs of tests and decreasing access?” We reply that in any system, it is important to strive for metrics that reveal the quality of the system, and burden should not keep the system from striving for the best solutions, particularly when it comes to the health of individuals.
We are certain that there will be increasingly innovative ways to automate the critical data aggregation. A high-quality system for genetic tests will take coordination and cooperation from industry, heathcare providers, government, payers, and patients. We look forward to moving ahead.