updated 11/6/2007 3:09:21 PM ET 2007-11-06T20:09:21

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.

  1. Don't miss these Health stories
    1. Splash News
      More women opting for preventive mastectomy - but should they be?

      Rates of women who are opting for preventive mastectomies, such as Angeline Jolie, have increased by an estimated 50 percent in recent years, experts say. But many doctors are puzzled because the operation doesn't carry a 100 percent guarantee, it's major surgery -- and women have other options, from a once-a-day pill to careful monitoring.

    2. Larry Page's damaged vocal cords: Treatment comes with trade-offs
    3. Report questioning salt guidelines riles heart experts
    4. CDC: 2012 was deadliest year for West Nile in US
    5. What stresses moms most? Themselves, survey says

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.

Copyright 2007 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

Discuss:

Discussion comments

,

Most active discussions

  1. votes comments
  2. votes comments
  3. votes comments
  4. votes comments