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Lack Of Regulation, Oversight For Genetic Tests

Armen Hareyan's picture

Genetic Tests

Federalregulation and oversight of genetic tests is inadequate and a growing number ofthe tests are being marketed with unproven, ambiguous, false or misleadingclaims, according to the final draft report of the NIH's Secretary's Advisory Committee on Genetics, Health and Society, the New York Times reports. The 15-member panelexamined tests that use cheek swabs, blood samples, biopsies and other tissuesamples to analyze DNA, RNA, chromosomes, genes, enzymes or other proteins todetect mutations related to diseases or health.

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According to the Times, the tests "can provide information tohelp prevent, detect and treat hundreds of conditions," such as cancer,heart disease and diabetes. However, according to the panel, people could beharmed if a test provides inaccurate results that lead to risky, unnecessarytreatment or denial of treatment that could be beneficial. The panel said that"there is currently no requirement that test providers discloseinformation to support claims about the accuracy and validity of testing,"adding that there is little scientific evidence of the tests' benefits. Inaddition, the panel noted that FDA "is not currently assessingthe clinical validity of most genetic tests," and physicians and patientscannot be sure a test will provide the promised results.

The panel also said that most physicians do not have adequate training andexpertise to interpret genetic test results, and many are not aware of theprofessional guidelines for their use. The panel noted that while professionalsocieties provide their members with up-to-date information, "they cannotkeep up with the pace of development of genetic tests." In addition, thepanel said many companies are marketing genetic tests directly to consumers,which raises "significant ethical concerns."

Some members of the genetic testing industry are open to federal regulatorystandards, but others believe that genetic experts are capable of setting theirown regulations, the Times reports. Alan Mertz, president of thetrade group American Clinical LaboratoryAssociation, saidthat excessive regulations and standards could "stifle innovation" ingenetics testing (Pear, New York Times, 1/18).

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