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Genetic testing system is badly flawed, experts say

May 5, 2009 | 10:59 am

Genetic tests that predict a person's risk of disease or suggest which types of treatments may succeed or fail are taking center stage in medicine. However, the lack of consistent government oversight of the testing industry poses enormous concerns for consumers and health professionals, experts said in a letter to Kathleen Sebelius, secretary of the U.S. Department of Health and Human Services.

The letter, signed by a diverse coalition of groups representing genetic testing laboratories, patient advocates, investors and health policy researchers, called for a new framework to oversee genetic testing that is consistent for all tests.

"Advanced diagnostic testing is becoming the standard of care for many diseases," the letter said.

Right now, various tests are subjected to different levels of regulation. Two types of testing systems are available: test kits approved by the Food and Drug Administration and laboratory-developed tests that are regulated by the Department of Health and Human Services. But this system is inconsistent and fails to protect all consumers, said Kathy Hudson, director of the Genetics and Public Policy Center at Johns Hopkins University. Some genetic testing labs, for example, are not subjected to proficiency testing to ensure accuracy and quality, Hudson said today at the annual meeting of the American College of Obstetricians and Gynecologists in Chicago.

"The problem is there is no system that makes the requirement of proficiency testing for every company," she said. "There is no way for the public to distinguish between the good guys and the bad guys."

Studies conducted at the Genetics and Public Policy Center and other organizations have shown a wide range of quality in genetic testing. In one study, researchers sent identical medical and genetic information to a company twice with a different patient's name on each test. The company produced different genetic findings for the two "identical" patients, Hudson said. In another situation, a gene testing company touting a service to identify the gender of a fetus based on a blood test from the mother predicted the gender accurately only half of the time -- the equivalent of guessing.

In the letter to Sebelius, the coalition also called for a registry that would include the name of the laboratory performing a test, the name of the company that developed the test and information to support claims of how valid the test is.

Hudson noted that the call for consistent, rigorous regulation of genetic testing comes from diverse groups representing industry and patient interests. "The level of consensus here truly represents a watershed moment in laying this critical foundation for personalized medicine."

-- Shari Roan

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