Govt. calls for better genetic testing regulation

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Govt. calls for better genetic testing regulation

Report expresses concern that screenings aren't consistently

monitored

http://www.msnbc.msn.com/id/21656660/

WASHINGTON - Increased supervision of genetic testing is needed to

ensure the usefulness of the increasingly popular tests, often

promoted as a way to personalize medical treatment, a U.S.

government draft report suggested Tuesday.

These tests look for genetic disorders and are used for such things

as screening unborn babies for disease, testing for inherited

diseases in adults before symptoms begin, confirming disease

diagnoses and helping people who may be susceptible to some ills

plan lifestyle changes.

According to the U.S. National Institutes of Health, about 900

genetic tests are available.

But in recent years concern has grown about whether they and the

laboratories that carry them out are sufficiently regulated. The

Department of Health and Human Services formed an advisory committee

to look into the matter.

That committee's draft report, released Tuesday, found significant

gaps in regulation and urged the government and private businesses

to work together.

Some testing, such as those for caffeine metabolism and fetus gender

testing are " skirting the boundaries " of current regulation, the

report concluded.

It said the Clinical Laboratories Improvement Amendments of 1988,

which cover lab regulations, should be expanded to cover genetic

testing.

An array of federal agencies including the Centers for Disease

Control and Prevention, Center for Medicare and Medicaid Services,

Food and Drug Administration and Federal Trade Commission should

strengthen monitoring and enforcement of laboratories that make

false and misleading claims for genetic tests, the report said.

The report also said there is insufficient information on the

clinical usefulness of genetic testing and said HHS should finance

an assessment of the tests.

That is particularly important because insurance companies are

increasingly require evidence of clinical utility before they will

pay for the tests, the report said.