By Kirell Lakhman
Clinical labs and others interested in the NIH's plan to create a voluntary Genetic Testing Registry have until Monday, July 12 to comment on it what it will resemble and how it will work.
In March, when it announced the planned registry, the NIH said it would design it to "enhance transparency" of the 1,600 or so genetic tests currently available to patients and consumers, and, eventually, to enable researchers to learn from them to develop new ones.
Hoping to "enhance access to information about the availability, validity, and usefulness" of such assays, the proposed registry is, thankfully, tacks away from recommendations made two years ago by the HHS Secretary’s Advisory Committee for Genetics, Health, and Society to build a mandatory registry.
And as I wrote when the NIH announced the database, the agency would be wise to keep it voluntary; a mandatory registry would shoulder the fledgling genetic-testing industry — both its private and public sectors — with an unbalanced burden of disclosure. As it is it's not clear whether the private sector will foot part of the bill.
The voluntary nature of the database is opposed by groups such as the Genetic Alliance, the Genetics and Public Policy Center, and the Coalition for 21st Century Medicine, which have spent several years calling for a mandatory registry.
Indeed, when the NIH announced the registry in March the groups said they "look forward to [it] becoming mandatory so that we are all apprised of the quality and availability of genetic testing across the nation.”
Would a voluntary registry, assuming it would require the same kinds of data as a mandatory one, preclude a test's quality and availability?
For its part, the NIH said the registry would aim to "encourage" genetic test providers to "enhance transparency" by publicly disclosing any and all information about the "availability and utility of their tests."
It would also serve as "an information resource" for all comers, especially patients, who would presumably use it to locate lab that offer tests they're after.
And in a nod to advancing R&D, the registry would "facilitate genomic data-sharing for research and new scientific discoveries."
As NIH Director Francis Collins put it, the database "will help consumers and health care providers determine the best options for genetic testing, which is becoming more and more common and accessible."
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