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More Regulation Urged For Genetic Testing

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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, according to a government draft report 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 National Institutes of Health there are about 900 genetic tests available.

But in recent years concern has grown about whether there is sufficient regulation of the tests and the laboratories that do them, prompting the Department of Health and Human Services to form an advisory committee to look into the matter.

That committee's draft report, released Tuesday, found significant gaps in regulation and called on 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 not sufficient information on the clinical usefulness of genetic testing and called on HHS to fund an assessment of these tests.

That is particularly important because insurance companies are increasingly requiring evidence of clinical utility before they will pay for the tests, the report said.