Navigation Links
Experts say direct-to-consumer genetic tests need innovative oversight

HOUSTON, Oct. 8, 2010 Direct-to-consumer (DTC) genetic tests available from retailers and the Internet let people learn about their genomes without going to a doctor, but they raise the question of who is responsible for oversight and regulation of these tests. Critics worry about safety risks if consumers base important lifestyle or medical decisions on inaccurate or misunderstood test results.

A group of four leading bioethical, legal and medical researchers believes the solution will require an innovative approach that combines premarket studies done before tests enter the market with ongoing postmarket evaluations to confirm how well tests perform once they are in use. Because DTC tests move in a global Internet marketplace, close international cooperation also will be required.

The team, led by Amy L. McGuire of the Center for Medical Ethics and Health Policy at Baylor College of Medicine in Houston, also includes Barbara Evans of the University of Houston (UH) Law Center, Canadian legal expert Timothy Caulfield and Wylie Burke, M.D., of the University of Washington School of Medicine. The group's policy recommendations for DTC genetic tests appear in the Oct. 8 issue of Science magazine, the world's leading journal of original scientific research, global news and commentary.

In their Science article, the authors note that more than 90 percent of the genetic tests now available in the United States have never been through a regulatory review to prove the tests are safe and actually improve human health. A broad consensus exists for some form of regulatory review before new tests enter the market, but potential solutions have been mired in controversy. There are practical barriers to forcing all new genetic tests to go through the same sort of data-intensive premarket review the Food & Drug Administration requires for other medical products, such as drugs.

"Many genetic tests make long-term predictions, and there 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.


Contact: Lisa Merkl
University of Houston

Related medicine news :

1. Experts advocate realigning type 2 diabetes treatments with diseases natural history
2. Experts urge making cigarettes non-addictive a research priority
3. Decline in Adult Smoking Stalls, Alarming Experts
4. Experts recommend universal screening of newborns for congenital adrenal hyperplasia
5. Nations leading ID experts call for mandatory flu vaccine for all health-care personnel
6. Eggs Being Produced by Recall Farms Safe, if Pasteurized, Experts Say
7. Experts Predict Normal H1N1 Flu Season This Year
8. Experts Support FDA Panels Backing of New Blood Thinner
9. Sunscreen Concerns Unfounded, Experts Say
10. Experts Issue New Guidelines on Breast Cancer Drugs
11. Experts Believe Many Birth Defects Are Preventable
Post Your Comments:
(Date:10/13/2017)... ... 2017 , ... “America On The Brink”: the Christian history of the United ... the creation of published author, William Nowers. Captain Nowers and his wife, Millie, ... spent thirty years in the Navy. Following his career as a naval aviator ...
(Date:10/12/2017)... ... 2017 , ... Planet Fitness, one of the largest and fastest growing franchisors ... a flagship location in Covington, LA at 401 N. U.S. Highway 190, in January ... Office Depot in the Holiday Square shopping center. Its location allows it to serve ...
(Date:10/12/2017)... ... October 12, 2017 , ... The American College of Medical ... Friedman, PhD, FACMI, during the Opening Session of AMIA’s Annual Symposium in Washington, D.C. ... honor of Morris F. Collen, a pioneer in the field of medical informatics, this ...
(Date:10/12/2017)... ... 2017 , ... Dr. Parsa Mohebi, the Los Angeles based ... the newly revamped Cosmetic Town journal section, featuring articles written by ... as Follicular Unit Extraction (FUE). , Dr. Mohebi says “I enjoy ...
(Date:10/12/2017)... ... 2017 , ... On Saturday, October 21, the Health & Wellness Center at ... raise money for the American Heart Association Heart Walk. Teams of up to 10 ... to keep their treadmills moving for 5 hours. Treadmills will start at 7:00 p.m. ...
Breaking Medicine News(10 mins):
(Date:10/2/2017)... 2017 Halo Labs announces the European launch of their ... HORIZON at MIBio 2017 in Cambridge, U.K ... matter in biopharmaceutical samples with unprecedented speed and sensitivity while using ... Backgrounded Membrane Imaging. ... subvisible particle analysis system ...
(Date:9/27/2017)... Israel and NEW YORK , Sept. 27, ... with mobile health and big data solutions, today announced that its MyDario ... Please check your local TV listings for when The Dr. Oz Show ... ... season this month. ...
(Date:9/22/2017)... SAN DIEGO , Sept. 22, 2017 ... ll medical device is now successfully helping those with ... Union. Fibromyalgia diagnosed Amanda in ... getting dressed and washing my hair, experiencing no sleep ... body in painful spasm… I cannot recommend [the AVACEN ...
Breaking Medicine Technology: