-- HealthDay staff
TUESDAY, March 8 (HealthDay News) -- The U.S. Food and Drug
Administration began a two-day hearing Tuesday to weigh the risks
and benefits of those increasingly popular direct-to-consumer
These tests, their manufacturers contend, can help predict a
person's risk of disease or how someone might respond to a given
A panel of FDA advisers will look only at those genetic tests
sold directly to consumers without the involvement of medical
professionals. The kits enable people to have their genetic
material analyzed to identify variations that might be related to
inherited disorders, such as cystic fibrosis, breast cancer and
even Alzheimer's disease.
While the FDA isn't compelled to follow the recommendations of
its advisory panels, it usually does so.
This relatively new category of tests sprang up as a result of
the U.S. Human Genome Project, begun in 1990, which boosted
understanding of human health, disease and genetics, the FDA
explained in a background summary released Tuesday. Because the
field is so new, little is known about the accuracy of home genetic
tests or the implications of test results, particularly if a
health-care professional isn't involved to help consumers interpret
Currently, only home tests that make medical claims are
regulated by the agency.
Last year, Pathway Genomics announced that it would start
selling tests (in general, the test can cost from $400 to $2,000)
at Walgreens stores, which are ubiquitous in the United States.
Walgreens reversed its decision, however, after the FDA raised
questions about the supplier.
Before drafting regulations for the direct-to-consumer tests,
the FDA has asked its advisers and test manufacturers for input in
a variety of areas, including the reliability of the tests; the
possibilities for misuse; the likelihood -- and consequences -- of
misunderstood results; and how a lack of counseling might affect
people who receive disturbing results.
Consumers can take a sample of their saliva or blood, for
example, and send it to a clinical laboratory for analysis without
guidance or oversight from a medical professional. Patients must
initiate any medical follow-up or counseling on their own.
Because people might make medical decisions based on the test
results, the FDA will likely set standards to minimize the chance
of misuse or misinterpretation of test results, similar to
standards governing prescription-only genetic tests or home tests
such as pregnancy tests.
Other considerations will include how to categorize the
different types of home genetic tests. Three possibilities, the FDA
said, include: tests that screen for carriers of a heritable
disorder; tests that predict risk for a disorder such as ovarian
cancer in people with no symptoms; and tests claiming to predict
how someone will respond to a particular drug or medical
While test makers are expected to defend their products, test
accuracy is a key concern of skeptical medical professionals. A
recent undercover study of 15 direct-to-consumer genetic tests by
the U.S. Government Accountability Office found "egregious examples
of deceptive marketing, in addition to poor or nonexistent advice
from supposed consultation experts." That report was published in
Whether the test results are clinically valid or clinically
useful is also a concern. Dr. Bruce R. Korf, president of the
American College of Medical Genetics, recently told
HealthDay that inaccurate results could create a sense of
Someone who learns he or she is at reduced risk for type 2
diabetes, for example, might figure they don't need to worry about
weight or diet, said Korf, who is also chair of genetics at the
University of Alabama at Birmingham. "The [test] may not give you
the whole story and may not even be true for [that patient]," he
Fears that test results might be emotionally devastating weren't
borne out by a recent study led by Dr. Eric Topol, director of the
Scripps Translational Science Institute in La Jolla, Calif.
"There have been proclamations that this would induce a tremendous amount of fear and trauma for people and speculation as to whether it would help at all," said Topol. But his study, published in January in the New England Journal of Medicine, found that consumers don't suffer great anxiety in the face of negative results, nor do they change their lifestyle habits in response to test results.
To learn more about genetics and disease, visit the
National Human Genome Research Institute.
Please be aware that this information is provided to supplement the care provided by your physician. It is neither intended nor implied to be a substitute for professional medical advice. CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with any questions you may have regarding a medical condition.
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