Navigation Links
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.


'/>"/>

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

Page: 1 2

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:
*Name:
*Comment:
*Email:
(Date:7/11/2014)... MA (PRWEB) July 11, 2014 ... at least $50 billion in fuel costs ... immediately. The current GHG standards ... have taken it upon themselves to install ... include: , 1.    Idle reduction technologies , 2.    Efficient ...
(Date:7/11/2014)... (PRWEB) July 11, 2014 Ticket Down ... the Concord Pavilion . When it comes to the summer ... Bryan. The 37-year-old Georgia native is one of the biggest names ... entertainment business. Bryan is currently out on his “That’s My Kind ... many stops the tour will be making through the rest of ...
(Date:7/11/2014)... Global enterprises today are shifting towards ... management activities. Managed services offer these global enterprises a ... slowdown resulted into rising operational costs to companies. The ... to be the global market driver for expanding the ... managed services market is estimated to grow from $142.75 ...
(Date:7/11/2014)... The Miriam Hospital have found that people with ... rates of smoking than those without mobility impairments. ... to attempt quitting than those without mobility impairments, ... for this population. The study and its findings ... the American Journal of Public Health . ...
(Date:7/11/2014)... (HealthDay News) -- Delaying surgery to repair damage to the ... middle of the knee -- could increase a young athlete,s ... medical records of 130 patients, aged 8 to 16, who ... less than six weeks after their injury, 37 had surgery ... more than three months after their injury. The youngsters ...
Breaking Medicine News(10 mins):Health News:LeaseQ Agrees the Latest Round of Greenhouse Gas Rules Could Increase the Cost of Truck Acquisition and Maintenance 2Health News:LeaseQ Agrees the Latest Round of Greenhouse Gas Rules Could Increase the Cost of Truck Acquisition and Maintenance 3Health News:Luke Bryan Ticket Prices Slashed at Concord Pavilion 2Health News:Luke Bryan Ticket Prices Slashed at Concord Pavilion 3Health News:North America Managed Services Market Worth $68.65 Billion by 2018 - New Report by MicroMarket Monitor 2Health News:North America Managed Services Market Worth $68.65 Billion by 2018 - New Report by MicroMarket Monitor 3Health News:North America Managed Services Market Worth $68.65 Billion by 2018 - New Report by MicroMarket Monitor 4Health News:Miriam Hospital study examines smoking prevalence 2Health News:Delaying Kid's Knee Surgery Could Be a Bad Play, Study Finds 2
... even flying in business class can put people at ... flights.// ,The link between blood clots (venous ... War II, when doctors noticed a rise in fatal ... in London air raid shelters. The association was further ...
... simple new test to detect kidney cancer in its ... report published in this week’s Cancer Research, researchers outline ... urine., ,Kidney cancer accounts for about 3 percent ... the United States in 2003. Doctors currently use several ...
... Programs run by nurses and dieticians have been found ... analysis has shown they work only when these health ... ,Researchers looked at a program in which patients received ... by nurses and dieticians on factors aimed at improving ...
... A new study reveals that a tonsillectomy procedure using ... key to reducing pain during recovery. // ... scalpel heats tissue as it goes along to control ... less energy to achieve the same result, which means ...
... New research shows the drug efalizumab may reduce symptoms ... ,Researchers from Loyola University studied more than 550 ... efalizumab (Raptiva) or a placebo for three months. Researchers ... the degree of scaling and thickness. Patients also completed ...
... publishing in the most recent issue of The Lancet ... for the deadly Ebola virus.// ,In a ... a factor known to inhibit blood coagulation called rNAPc2 ... kills its victims by causing severe hemorrhagic fever. This ...
Cached Medicine News:
(Date:7/10/2014)... Ariz. , July 10, 2014   Ventana ...  Group, today announced it has entered into an agreement ... which operates as EMD Serono in the ... , to collaborate with Merck KGaA,s biopharmaceutical division on ... for an undisclosed target using Ventana,s proprietary diagnostic assays. ...
(Date:7/10/2014)... BURLINGTON, Mass. , July 10, 2014 ... nephrologists report awareness of the U.S. Food and Drug ... Pharma,s new phosphate binder Velphoro, which was approved by ... hyperphosphatemia in chronic kidney disease (CKD) patients on dialysis. ... TreatmentTrends: Nephrology (US) Q2 2014 ...
(Date:1/15/2014)... Markets ( http://www.researchandmarkets.com/research/6k27gw/dental ) has announced the addition of ... Size, Share, Growth, Trends And Forecast, 2013 - 2018" ... http://photos.prnewswire.com/prnh/20130307/600769 ) Dental consumables ... to treat dental impairments, for tooth restoration and in ...
Breaking Medicine Technology:Ventana Medical Systems, Inc. and Merck KGaA, Darmstadt, Germany to develop companion diagnostic test for cancer treatment 2Ventana Medical Systems, Inc. and Merck KGaA, Darmstadt, Germany to develop companion diagnostic test for cancer treatment 3Half of Surveyed Nephrologists Report Moderate Familiarity with Velphoro, Which Received FDA Approval Late Last Year for the Treatment of Hyperphosphatemia in Dialysis 2Half of Surveyed Nephrologists Report Moderate Familiarity with Velphoro, Which Received FDA Approval Late Last Year for the Treatment of Hyperphosphatemia in Dialysis 3Dental Consumables Market - Global Industry Analysis, Size, Share, Growth, Trends And Forecast, 2013 - 2018 2Dental Consumables Market - Global Industry Analysis, Size, Share, Growth, Trends And Forecast, 2013 - 2018 3
... NEW YORK, Sept. 28, 2011 Visionsense Corp announces ... was used in its 500th neurosurgical procedure with the ... (Al Lerner Chair and Vice-Chairman, Dept of Neurosurgery at ... performed a transsphenoidal resection of a pituitary adenoma in ...
... Sept. 28, 2011 As part of its ongoing work ... settings, Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today its ... event and global MRSA summit will be held on October ... Maywood, Ill. Organized by the MRSA Survivors ...
Cached Medicine Technology:Roche Diagnostics Supports Fight Against MRSA as a Sponsor of Annual World MRSA Day on October 1 2
... grafting or creation of a vascular access, ... is of the utmost importance in many ... for those seeking a high-precision tunneling instrument. ... risk of twisting or kinking for more ...
... have met the challenges of the ... exceptional performance and quality, they have ... worldwide. These grafts require no preclotting, ... infection, and ensure utmost thrombectomy safety. ...
... the challenges of the most demanding vascular ... exceptional performance and quality, they have earned ... grafts require no preclotting, resist dilatation and ... thrombectomy safety. Gore vascular grafts are also ...
... the newest vascular graft offering from W. ... vascular surgical products for more than two ... and compression problems that can lead ... all of the benefits of a ring ...
Medicine Products: