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Genetic testing in need of supervision to prove its usefulness

Strict supervision of genetic testing will prove the usefulness of tests, often promoted as a way to personalize medical treatment.

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.

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