The National Institutes of Health has announced that it is creating a public database to enhance access to information about the availability, validity and usefulness of genetic tests. The Genetic Testing Registry (GTR) is projected to help researchers, consumers, healthcare providers and others search for information submitted voluntarily by genetic test providers.
Currently, more than 1,600 genetic tests are available to patients and consumers, but there is reportedly no single public resource that provides detailed information about them. GTR is intended to fill that gap. It will enable developers and performers of genetic tests, including the most innovative and cutting edge genetic tests, to consolidate information about the availability and utility of their tests in a single searchable database. This information is critical to the appropriate development and maintenance of a risk-based regulatory system that both assures patient safety and promotes innovation to advance personalised medicine.
The GTR project will be overseen by the NIH Office of the Director. The National Center for Biotechnology Information (NCBI), part of the National Library of Medicine at NIH, will be responsible for developing the registry, which is expected to be available in 2011. GTR genetic test data will be integrated with information in other NIH/NCBI genetic, scientific, and medical databases to facilitate the research process. It is expected that this integration will allow scientists to make, more easily and effectively, the kinds of connections that ultimately lead to discoveries and scientific advances.
During the development process, NIH will engage with stakeholders - such as genetic test developers, test kit manufacturers, healthcare providers, patients, and researchers - for their insights on the best way to collect and display test information. In addition, other federal agencies, including the Food and Drug Administration and the Centers for Medicare and Medicaid Services, will be consulted.
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