13 April 2009
The Genetics and Public Policy Center (GPPC) at Johns Hopkins University has reportedly produced a document setting out proposals for the implementation of a compulsory web-based registry of genetic tests in the US, as proposed by the Secretary’s Advisory Committee on Genetics, Health and Society (SACGHS) to the US Department of Health and Human Services (HHS) last year (see previous news). Speaking at the American College of Medical Genetics' Annual Clinical Genetics Meeting in March, GPPC deputy director Joan Scott said that the paper, which had been accepted for publication, was intended to stimulate discussion about the best way to implement the resource (see Pharmacogenetics Reporter article).
The document proposes a national web-based registry combining information from existing resources such as the GeneTests website with data from genetic testing laboratories, to include information on the purpose, analytical validity, clinical utility and validity of each test. Oversight of the registry would be crucial, with the GPPC proposing that the HHS has the legal authority to oversee its implementation, or to devolve that authority to another agency.
However, whereas the original SACGHS recommendations were for a mandatory registry to include all laboratory tests, the GPPC proposes that only genetic tests should be included, although the definition of a genetic test is not clarified (for example, whether this would include non-DNA based tests that indirectly reveal information about a genetic condition).