![]() ![]() The consequences of the current fragmented and anemic oversight system for providers and patients potentially are grave. The recent entry into the marketplace of genetic tests sold directly to consumers (DTC) without external scrutiny brings added immediacy to these concerns and has renewed governmental attention to the broader question of genetic testing oversight. However, government oversight does not ensure adequately that tests can provide accurate and meaningful health information to doctors and patients, nor does it require those offering tests to disclose the evidentiary basis for the claims they make about their tests. 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.Īs genetic testing becomes an increasingly important part of clinical practice, it is imperative that health care providers, payers, and patients in both the United States and other countries have access to high-quality tests and to information about how to order and interpret them appropriately. 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 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 propose a ‘blueprint’ for the creation of a genetic test registry in order to expedite its implementation. A recent government recommendation for a mandatory genetic test registry has received wide stakeholder support but leaves many practical questions unanswered. 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. Information gaps impede informed decision making by health care providers and patients. While the number of genetic tests continues to grow, publicly accessible information about the analytic and clinical validity of such tests is lagging. ![]()
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