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AMP Members Concerned About NIH's Planned Genetic Test Registry

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – In a written response to the National Institutes of Health, the Association for Molecular Pathology said that its members have deep concerns over the NIH's plans for a Genetic Test Registry.

The comments were submitted by AMP yesterday in response to NIH's request for comments on its planned registry, which would be a resource of information for healthcare providers and patients to learn about tests and labs, and for researchers and regulators to watch the genetic testing industry.

In its response, the association said that in a survey conducted among its members, respondents said that there are numerous reasons for participating in a voluntary registry including that it would provide a resource to clinicians and the public about the tests being offered; would increase transparency; streamline testing; improve data-sharing; and standardize tests.

But respondents also cited a number of worries. For example, less than 60 percent were willing to provide analytical and clinical validation information to the GTR. Two-thirds said the registry would have a moderate to significant impact on their library, and 12 percent said they would stop offering a test if required to participate in the GTR.

AMP also said that many respondents are concerned about how the GTR would interface with currently available registries, such as GeneTests. NIH would need to ensure that its registry would not be redundant "and would not overly burden laboratories' limited resources to comply and update information," the association said in a statement.

It added that respondents were worried about use of the registry by competitors, payors, and regulators.

"We hope the NIH would continue to actively engage the molecular laboratory community as it works to implement a GTR," said Karen Mann, AMP's president.

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