WASHINGTON, DC .- Tens of geneticists have shown at a public meeting today at the center one day conference here and expressed concern about a planned register of genetic testing administered by the National Institutes of Health (NIH). The gathering, an opportunity to discuss concerns anyone in the community has with the register highlighted ongoing concerns about how the registry will work and whether it will let consumers who think that it tests listed are all scientifically sound.
The registry aims to provide information on genetic testing for health care providers, researchers and consumers. But from the moment it was first announced in March, it has been criticized for being voluntary, ie not to require companies list their tests, something that NIH does not have the legal power to do. NIH also does not plan to conduct a scientific review of the tests listed in the database.
Since NIH put the word on its register, genetic tests have been even more control than ever before, making the register both potentially most important, there is nothing another like him there, but also generate more scrutiny. FDA crushed an attempt by Pathway Genomics to sell genetic tests Walgreens chain pharmacies, and an office of the Government Accountability (GAO) investigation of the summer found that genetic testing companies representatives provided information false or doubtful customers.
At the beginning of today's meeting, James Ostell, head of the Information Engineering Branch at the NIH National Center for Biotechnology Information, unveiled a prototype of the database . To address some of the 68 NIH comments received, the page featured example of a tab marked "powers" where companies could list their licenses and certifications. There was also a green marker indicating FDA approval.
However, participants in the meeting were impressed. Many, including Sherri Bale, co-president and clinical director of GeneDX, a company that specializes in genetic testing for rare diseases, called for the database to be limited to only highly validated tests. "Medically relevant genetic testing Only the highest quality should be represented in the register," she said.
This could be the ideal-have some sort of scientific review of test-listed is just not an option for NIH at this time, said director Francis Collins, who spoke at the beginning of the day. "To be honest, it will require resources beyond our means and authority […] to primary performance data," he said.
But without independent reviews, many at the meeting argued, health care providers or consumers may feel the test is clinically validated just because it is included in a database NIH sponsored data. Many of the participants at the meeting hoped that the database at least featured an optional review process.
"Leaving aside professional assessment, I think, would be a mistake," said Robert Nussbaum, a medical geneticist at the University of California, San Francisco. "If we will do it, do it right."
NIH plans to weigh these issues over the coming months. It is hoping to launch the full database in spring 2011.
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