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Government Finds Little or No Useful Predictive Risk Information
[By Staff Reporters]
WASHINGTON — U.S. government investigators say personalized DNA tests that claim to predict a person’s likelihood of developing diseases are misleading and offer little or no useful information.
Link: http://www.msnbc.msn.com/id/38363300/ns/health
Assessment
The Energy and Commerce Committee recently heard testimony from the FDA and three genomic testing companies: 23andMe, Navigenics and Pathway Genomics Corp.
Government Report: Genetic tests
Conclusion
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Filed under: Breaking News, Ethics, Research & Development, Risk Management | Tagged: 23andMe, DNA tests, Navigenics and Pathway Genomics Corp |
The Leading Business Education Network for Doctors, Financial Advisors and Health Industry Consultants 
On DTC genetic testing
Currently, there are more than 2,000 genetic and genomic tests for inherited and acquired disorders on the market in the United States. With an annual growth rate of 25%, this rapidly growing field has created challenges for healthcare professionals as patients have unrealistic expectations on the availability (or lack of availability) of medical options for tested diseases.
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In response to recent publicized concerns over direct-to-consumer (DTC) genetic testing, a hearing was held on July 22, 2010, by the Oversight and Investigations Subcommittee of the Committee on Energy and Commerce. The highlight of this meeting was the presentation of a report on an investigation conducted by the Government Accountability Office (GAO) on DTC testing companies. The results of this two-tier investigation, which involved risk predictions for 15 disorders using duplicate specimens for 5 individuals sent to 4 DTC companies, showed a high level of discrepant results and a lack of risk figures provided for individuals described as “African American” or “Asian.”
The GAO also anonymously contacted 15 DTC testing companies to ask about their services and claims made on websites. In 67% of cases, fraudulent claims were made, ranging from false claims of celebrity endorsement to overblown claims of the power of the tests, among others. Two companies also indicated that a woman could test her fiancé’s DNA sample without his knowledge as a “surprise,” despite that surreptitious testing is illegal in 33 states.
Dr. Diane J. Allingham-Hawkins can answer your questions about the growing concerns associated with genetic tests marketed directly to consumers; she can also offer expert insight into the congressional hearing on direct-to-consumer genetic testing, as well as the recently held meetings on Food and Drug Administration (FDA) oversight of laboratory-developed tests. Dr. Allingham-Hawkins is Director of the Genetics Test Evaluation Program at Hayes, Inc., an unbiased healthcare research and consulting firm that is helping hospitals and insurers cope with the cost and ethical issues related to genetic testing. The Hayes GTE program provides independent reviews of genetic tests and addresses such questions as, Do these expensive tests do what they are supposed to do?
Dr. Diane J. Allingham-Hawkins is an outspoken interviewee with in-depth knowledge of the subject matter and very pointed opinions about genetic testing. A great interview!
http://energycommerce.house.gov/index.php?option=com_content&view=article&id=2083:hearing-on-direct-to-consumer-genetic-testing-and-the-consequences-to-the-public-health&catid=133:subcommittee-on-oversight-and-investigations&Itemid=73
Thank you for considering.
Karen Matthias RN, MBA
Vice President
Hayes, Inc. 215.855.0615
kmatthias@hayesinc.com
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Direct-to-Consumer Genetic Tests: Boon or Bane?
Hayes, Inc., a leader in health technology assessment, invites you to participate in this free 1-hour live webinar on December 14, 2010, at 1:00 PM (ET).
Advances in genetic and genomic technologies have exponentially increased the amount of information available to healthcare providers and their patients. Simultaneously, a philosophical shift toward consumer-driven healthcare and patient empowerment has changed the landscape of traditional healthcare. Therefore, healthcare professionals have a critical role in ensuring the appropriate use of and access to direct-to-consumer (DTC) genetic tests. Because this topic is extremely important for all healthcare professionals, we would like to extend an invitation for you to attend this special Hayes webinar.
Learning Objectives
After attending this webinar, participants should be able to:
* Describe some of the currently available DTC genetic tests
* Explain testing methodologies
* Review the evidence associated with these tests
* Discuss reporting practices and recent regulatory developments
* Identify risks and benefits associated with DTC genetic testing
Date: December 14, 2010
Times: 1:00 PM – 2:00 PM ET
Webinar participants will be able to submit questions at least 24 hours before the webinar, as well as have the opportunity to ask questions at the end of the presentation.
If you have questions about the webinar, please e-mail us at:
educationservices@hayesinc.com
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Should you consider genetic testing?
Some of your relatives have had cancer. And, you’ve heard that people with a family history of the disease may be more likely to get cancer.
So, should you consider genetic testing to find out if cancer runs in your family? Here’s what you need to know, from Karen Lu MD,to make a more informed decision.
http://www.kevinmd.com/blog/2011/12/genetic-testing.html
Dr. David Edward Marcinko MBA
[Editor-in-Chief]
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