Center Applauds NIH's Newly Announced Genetic Test Registry As An Important Firs

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Center Applauds NIH's Newly Announced Genetic Test Registry As An Important

First Step

http://www.dnapolicy.org/news.release.php?action=detail & pressrelease_id=138

The Genetics and Public Policy Center at the s Hopkins Berman Institute of

Bioethics applauds today's announcement by the National Institutes of Health

that it will establish a voluntary genetic test registry and encourage genetic

test providers to share information about the availability and utility of their

tests.

Although experts at the Washington, D.C.-based center have pushed for the

creation of a mandatory registry for several years, a voluntary database is an

important first step, said Center Director Joan , M.S., C.G.S.

" We are very pleased that NIH is taking the first step in developing a genetic

test registry and we hope that all laboratories offering genetic tests will

participate, " said. " It is critical for health care providers and patients

to have easily accessible information about what tests are available, when their

use is indicated, and what data support their accuracy and reliability in order

to make informed decisions about their use. "

In the August 2009 issue of Public Health Genomics, , research scholar Gail

Javitt, J.D. M.P.H., and their co- authors argued that a mandatory registry of

genetic tests would be a crucial first step toward increasing the quality and

transparency of the widely available services.

Genetic tests are now available for more than 1,600 conditions, and can form the

basis for decisions about disease treatment and prevention, and whether or not

to have children. An increasing number of tests are available directly to the

consumer. " Yet oversight of genetic tests has not kept pace with the increasing

availability and complexity of such tests, " the Center has argued.

Just last week, the Center released an updated list of direct-to-consumer

genetic testing companies, available at http://www.dnapolicy.o rg.

In their paper, " Developing the Blueprint for a Genetic Testing Registry, "

and Javitt suggested that the NIH would be an ideal agency to oversee the

listing-because of its extensive expertise in registry development and

implementation.

The Center has long advocated for a testing oversight system that will ensure

that laboratories can document their ability to perform tests accurately and

reliably, tests are shown to be valid and effective, claims about tests are in

keeping with the scientific evidence, and health care providers and patients are

armed with the tools and information necessary to make testing decisions.

The Genetic Test Registry is expected to be available in 2011. For more

information, visit http://www.ncbi. nlm.nih.gov/gtr/.