![]() ![]() The Internet has vastly expanded the ability of doctors and patients to learn about new tests regardless of where the laboratory performing them is located, and the rise of DTC testing has allowed companies offering tests to target consumers directly in the United States and abroad. The lack of transparency has implications for both the United States and other countries. Nor has HHS yet acted on SACGHS’s recommendation to appoint and fund a lead agency to develop and maintain the mandatory registry for laboratory tests. ![]() In the United States, many stakeholders, including test manufacturers, laboratories, patient advocacy groups, and associations of health care providers, support the development of a genetic test registry, but there has been little practical discussion of how such a registry would be implemented, what data should be included, which agency within the federal government has the legal authority and institutional capacity to oversee it, or how compliance would be ensured. Such a registry would address ‘information gaps in the availability of tests and their analytic and clinical validity’ and ‘empower both consumers and providers by arming them with reliable information about what is known and not known about the quality and validity of tests’. The Committee recommended that clinical laboratories and others offering testing services be required to submit information about a test’s analytic and clinical validity to a publicly accessible laboratory test registry. Department of Health and Human Services (HHS), became the latest body to conclude that there are ‘significant gaps’ that could harm public health in the U.S. In April 2008 the Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS), which advises the Secretary of the U.S. Calls for enhancing transparency have come from Congress as well as from advocacy groups and academic institutions. Specifically, more publicly accessible information is needed about what tests are being offered, for what indications tests are being offered, and the analytic and clinical validity of tests. Įnhancing the transparency of information about genetic tests is a key prerequisite to improving oversight. On the other hand, access to new, health-improving tests may be undermined by both lack of market incentives and unduly burdensome regulation. ![]() On the one hand, the premature use of tests that lack adequate validation or proper interpretation may lead to ill-informed treatment decisions and may undermine confidence in personalized medicine. 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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