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Experts say direct-to-consumer genetic tests need innovative oversight
Date:10/8/2010

ere may be decades of uncertainty before their risks and benefits are fully known," McGuire said. "If we wait until robust premarket data are available, that could delay development of new tests and essentially regulate many DTC companies out of existence."

"We favor a risk-stratified approach that tailors the regulatory requirements to the level of risk a DTC test actually presents," said Evans, who is also co-director of UH's Health Law & Policy Institute. "Genetic testing is not risky in itself, but a test can have significant risks if inaccurate results may lead to serious, irreversible medical decisions or if the test reveals troubling facts that cause psychosocial harm. A recreational test that tells you fascinating facts about who your ancestors were is fundamentally different from a cancer susceptibility test that may panic you to go get preventive surgery."

The article's authors suggest that regulators should pursue a hybrid approach that would continue to let most DTC tests reach the market quickly, with relatively light premarket review requirements. However, they believe that regulators should have the power to keep a higher-risk test off the market until studies confirm it has an acceptable risk-benefit ratio. For all tests, there is a need for enhanced postmarket follow up to confirm that the test is safe and effective, with prompt steps taken to protect the public if any problems emerge.

"The public needs frank disclosure of what is not known about these tests," Evans said.

The group concludes that collaboration among regulatory agencies and informal groups, such as the proposed National Institutes of Health Genetic Testing Registry, could yield the best possible result a market where consumers have ready access to most DTC tests and where innovation is encouraged, yet where sellers of high-risk tests would be required to meet more stringent pre-release standards.


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Contact: Lisa Merkl
lkmerkl@uh.edu
713-743-8192
University of Houston
Source:Eurekalert

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