By Lisa Seachrist
WASHINGTON — Noting the fact that federal regulations and medical practice have failed to keep up with the flurry of genetic discoveries and the burgeoning field of genetic testing, a joint National Institutes of Health and Department of Energy Task Force on Genetic Testing recommended a more stringent examination of testing laboratories and the utility of specific genetic tests.
Specifically, the task force recommended that the Clinical Laboratory Improvement Act (CLIA) of 1988 has no provisions for regulating labs that conduct genetic tests. The recommendations also call for an advisory committee to the Department of Health and Human Services, an advisory committee to the FDA, and a National Genetics Board to scrutinize whether a test can provide real benefit to the patient as well as calling on the medical profession to better educate doctors about genetics.
"I don't agree with all of the recommendations of the task force," said Tom Frank, medical director and vice president of education of Myriad Genetic Laboratories Inc., in Salt Lake City. "However, the industry and society can only benefit from CLIA regulations with some real teeth."
The recommendations, which appeared in Thursday's Federal Register, represent the work of bioethicists, academics, physicians and industry representatives who were charged with developing guidelines that would maximize the benefits and minimize the harms of genetic testing. The task force is soliciting comments on the recommendations until March 10, and the recommendations will not become final until after a public meeting scheduled for March 17-18.
The task force highlighted the fact that genetic tests are, more often than not, predictive of disease whereas much of current medical testing is to provide for people who are already ill. A positive test affects patients, their relatives and potential offspring. The task force is concerned that many genetic test are not 100 percent predictive and that often there is no satisfactory treatment options if a person does prove to have a genetic susceptibility. For example, there is no current treatment for Alzheimer's disease.
As a result, the task force recommends that the Secretary of Health and Human Services establish a federally chartered Advisory Committee on Genetics and Public Policy that would coordinate consistent genetic testing policies. The recommendations also call for that committee to establish a National Genetics Board (NGB) which would use as yet undecided criteria for the protection of human subjects to determine whether a genetic test is both valid and useful.
All tests performed with federal funds, such as those at research institutions, would require examination by an institutional review board (IRB) and would have to be submitted to the NGB. However, private companies providing tests would come under the aegis of FDA where the task force recommends the agency use current regulations to insist that the tests pass IRB review before becoming clinically available. They also recommended that the agency establish a Genetics Advisory Panel under the Medical Device Amendments which would advise the agency on approving genetic tests.
"I am a little disturbed by the recommendations of the Task Force," said Glen McGee, a bioethicist at the University of Pennsylvania and the author of "The Perfect Baby: A Pragmatic Approach to Genetic Testing. "They continually state that there needs to be criteria for allowing genetic testing into the clinic, yet they never say who will establish the criteria."
McGee noted that demand for a genetic tests comes much more quickly than the validation of the test. He agreed that some criteria for judging which tests should go into the clinic but notes, "what is missing from this report is the way we are going to get that criteria. Very simply, FDA does not have the money to regulate this."
However, McGee pointed out that federal regulations may be an unnecessary answer to the problem. He would rather see agencies like the FDA, National Institutes of Health and Centers for Disease Control and Prevention coordinate efforts with industry to establish the standards for genetic testing. "A joint task force between the Biotechnology Industry Organization [BIO] and these agencies could establish the standards for judging genetic tests before they are introduced into the market," McGee told BioWorld Today.
Myriad's Frank disagreed with the whole notion of regulating these tests differently from other medical test. "The task force is basically saying that it is not enough for a test to be accurate, correlate to the development of a disease, and have a medical use," he said. "For example, a PAP test does not test for cancer, it tests for cellular changes that increase your chances for cancer. Testing for BRCA1 and BRCA2 in women who have a family history of the disease [breast cancer] is not much different."
Allan Goldhammer, director of technical affairs for BIO said "there is a lot of critical thinking that we must do when it comes to genetic testing, but saying you can't supply the test should not be part of the equation."
McGee, Frank and Goldhammer are in agreement with the task force's recommendations that CLIA be strengthened. "There are already discussions about CLIA," Frank said. "And, industry is involved as it should be — we have the expertise in genetic testing." *