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US government urged to increase genetic test regulation

2 December 2005
By BioNews
Appeared in BioNews 337

The US Genetics and Public Policy Center has called for stronger federal oversight of genetic testing in the country. The move stems from concerns over the quality of some of the increasing number of genetic tests available to consumers. The centre, based at Johns Hopkins University, has written to the Centers for Medicare and Medicaid Services (CMS) to issue a proposed rule to create a genetic testing speciality under the Clinical Laboratory Improvement Amendments (CLIA) of 1988.

The CMS, part of the Department of Health and Human Services, is responsible for setting laboratory standards for other types of medical tests, such as those for blood sugar or HIV infection. In its letter to the CMS, Gail Javitt and Kathy Hudson of the Center note that 'for more than ten years, federal advisory committees have been calling upon the government to provide more oversight of genetic tests'. But despite accepting recommendations to improve oversight of genetic testing five years ago, the CMS has yet to act, the authors say.

A wide range of genetic tests are now available, most of which detect gene mutations associated with inherited disorders such as cystic fibrosis and Huntington's disease. But, according to Javitt, there are concerns about the accuracy of other tests being offered - such as one for determining the sex of a fetus, and one offered online for an 'addiction gene' that does not actually exist. She told the Baltimore Sun newspaper that she couldn't cite specific examples of inaccurate test results, since part of the difficulty is that there is no central government database for collecting such reports.

Industry groups say its members are already subject to sufficient oversight. Carolyn Jones, of the Advanced Medical Technology Association, said that most genetic testing is already governed by federal law, and overseen by either the CMS or the Food and Drug Administration. A spokesperson for the American Clinical Laboratory Association said that its members already follow strict ethical codes, but they would support 'some tweaking' of the rules to guard against inaccurate testing by non-members.

However, in their letter, Javitt and Hudson say that 'the absence of a specialty area for genetic testing with specifically tailored requirements for the now burgeoning genetic testing industry hampers CLIA's ability to oversee the quality of genetic testing and to adequately ensure its safety', adding 'we urge CMS to take urgent steps'. In a press release, Javitt concludes that 'it's time to move swiftly to protect the American public and publish a proposed rule'.

SOURCES & REFERENCES
Genetics and Public Policy Center calls for stronger federal regulation of genetic testing, USA
Medical News Today |  1 December 2005
Letter to Mark McClellan, Administrator of the CMS
Genetics and Public Policy Centre |  28 November 2005
Surge in genetic testing raises quality concerns
The Baltimore Sun |  30 November 2005
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