The US National Institutes of Health (NIH) has opened an online Genetic Testing Registry (GTR), containing information on the availability, validity and usefulness of genetic tests provided by the test providers.
Plans for the GTR were announced last year (see previous news); it is intended to provide a resource for ‘all who are struggling to make sense of the complex world of genetic testing’ and ‘advance the public health and research into the genetic basis of health and disease’ by acting as a central repository for data on the thousands of genetic tests currently available. Currently, the GTR provides data from the NIH resource GeneTests, but it is now open for submissions directly from genetic testing companies.
Comment: The limitations of this approach are obvious – voluntary data submission from companies and the lack of independent verification of this data by the NIH. The convenience of a central source of information may prove a great benefit to researchers, clinicians and the public, but it is also possible that inclusion in the federal agency database could lend inappropriate credence to claims made by test providers. It remains to be seen how effective self-regulation of the industry is in this regard.
Meanwhile, the US medical insurer UnitedHealth has released a new report on genetic and molecular diagnostics saying that the US market was worth $5 billion in 2010 alone, and could grow to $15-25 billion per year by 2021, so this is big business; however, the same report noted that the majority of currently available tests lacked the evidence of effectiveness needed by clinicians and patients.