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How Reliable Is that Genetic Test? Experts Propose a Registry With the Answer
There’s not enough transparency in the world of genetic testing, argue experts from the Genetics & Public Policy Center, so it’s time for a registry of the 1,700 or so currently available. “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,” the authors, Gail Javitt, Sara Katsanis, Joan Scott, and Center director Kathy Hudson, write in a paper appearing this week in Public Health Genomics.
The proposed registry, which they also explain how to implement, would provide information regarding the reliability of health-related genetic tests; how test results “relate to current and future disease risk”; and how useful results are in informing disease diagnosis, treatment, management, and prevention. All clinical laboratories and distributors that advertise for tests or provide result interpretations that are different from those offered by laboratories should be required to register, with the exception of “providers of tests for ultra-rare disorders,” the authors recommend. They also suggest penalties for laboratories that do not comply.
A genetic testing registry would be an important educational resource for patients, parents, and health care providers. In a recent podcast with Science Progress, bioethicist Sandra Soo-Jin Lee said that lack of access to interpretive information about genetic testing is more pressing than lack of access to the testing itself, and that understanding what the results mean for your health is the most complex and valuable part of the process.
The proposal for a registry that would include so many genetic conditions highlights the questions about patient protection that remain even after the Genetic Information Nondiscrimination Act, known as GINA, became law last year. GINA prohibits the use of information obtained from genetic testing to deny health insurance coverage or employment, but insurers are not required to cover the costs of prevention measures a genetic test indicates would be beneficial, Susannah Baruch explains in a recent SP article.
The authors of the new study also suggest that either the National Institutes of Health or the Food and Drug Administration maintain the test registry. NIH has “extensive expertise in registry development and implementation” and FDA “has significant enforcement capability,” they explain. Despite where the registry, if created, is placed, the paper insists FDA be responsible for enforcement of consequences for non-compliance.
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