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• W2095125375 abstract "While the number of genetic tests continues to grow, publicly accessible information about the analytic and clinical validity of such tests is lagging. Information gaps impede informed decision making by health care providers and patients. Enhancing the transparency of information about what tests are being offered, for which indications tests are being offered, and the analytic and clinical validity of tests is a key prerequisite to ensuring test quality. A recent government recommendation for a mandatory genetic test registry has received wide stakeholder support but leaves many practical questions unanswered. We propose a ‘blueprint’ for the creation of a genetic test registry in order to expedite its implementation. We describe the goals of a registry, propose criteria for the inclusion of registrants and tests in the registry, and define the categories of information that should be included for such tests. We discuss the sources of legal authority that empower the government to mandate that a registry be established and identify the federal agencies with the relevant expertise and resources to do so. We conclude that establishing a registry is a critical first step in the development of a more transparent, quality-centered system of oversight that will better inform and protect the public." @default.
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• W2095125375 date "2009-06-29" @default.
• W2095125375 modified "2023-09-23" @default.
• W2095125375 title "Developing the Blueprint for a Genetic Testing Registry" @default.
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• W2095125375 doi "https://doi.org/10.1159/000226593" @default.
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