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HHS Group Recommends Policies for Oversight of Genetic Testing

NEW YORK (GenomeWeb News) — Due to the growth and advancement of genetic testing, greater coordination between federal agencies and enhanced partnership between private industry and the government is needed to avoid the potential harm such tests could cause and to clarify federal regulations for test-makers, a government committee said in a draft report this week.
In response to a challenge posed by Department of Health and Human Services Secretary Michael Leavitt in a report last month to promote the advancement of personalized medicine and to clarify the government’s role in its future, a task force this week issued a slew of recommendations regarding government oversight of genetic tests.
The Secretary’s Advisory Committee on Genetics, Health and Society (SACGHS) report proposes taking a number of steps aimed at bridging gaps in knowledge about the genetic testing industry and developing ways to regulate it.
The committee recommends expanding the role of the Centers for Medicaid and Medicare Services, maintaining a flexible, risk-based approach at the US Food and Drug Administration for laboratory-developed tests, and promoting information exchanges about validation, quality control, and performance.
CMS should conduct programs to educate regulators and inspectors about details of genetic testing technologies and processes for laboratory inspections, SACHGS concluded. The group also deems it unnecessary to create a genetic testing specialty under CLIA, as CMS had previously planned to do, in order to address gaps in the oversight of laboratories that conduct genetic tests.
CMS should, however, expand the list of regulated analytes to include genetic tests for which proficiency testing is available, said the report. It should look to “relevant experts” when deciding which genetic tests should be added to the list of analytes, and it should offer incentives for PT providers to expand PT products for genetic testing, SACGHS recommended.
HHS, NIH, and CDC should continue their efforts with partners to enhance public reference databases of mutations and polymorphisms, as well as clinical reference sequence databases. The reference databases also should provide summary data on disease-related genes, according to the recommendations.
Kathy Hudson, director of the Genetics and Public Policy Center and a member of the secretary’s committee, told GenomeWeb Daily News today that the expanded role of CMS and the need for “enhancements of oversight of laboratories, particularly in the area of proficiency testing,” may be among the most important of the committee’s recommendations.
“That mirrors what we’ve been saying for two years,” Hudson said. “The challenge now is whether or not it will be adopted or implemented,” because the response from CMS to previous efforts to increase oversight of proficiency testing was “No. No. A thousand times no,” Hudson added.
Also important, Hudson feels, is the recommendation that the FDA would have “a clear authority” over kits and lab tests and would maintain the “flexible, risk-based approach” it already has.
The committee did not dive into the details of in vitro diagnostic test definitions, Hudson added. That is the FDA’s role, she said, and “you don’t want an advisory committee writing recommendations … for a rapidly changing field.”
The full HHS report can be found here.

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