American Society of Human Genetics speaks out on DTC testing
Posted Oct 22 2008 6:18pm
After a wonderful conference call with some friends regarding the future of personal genomes, I was heartened to see ASHG put out a statement on Direct To Consumer (DTC) testing. Here is what these learned individuals say.
Currently, DTC genetic testing is permitted in about half the states2 and is subject to little oversight at the federal level. In July 2006, the Government Accountability Office issued a report documenting troubling marketing practices by some DTC testing companies,3 and the Federal Trade Commission (FTC) issued a consumer alert cautioning consumers to be skeptical about claims made by some DTC companies
While DTC testing also encompasses paternity and ancestry testing, this policy statement addresses solely those genetic tests that make health-related claims or that directly affect health care decision making.
For a test to be of good quality, the laboratory performing it must be able to obtain the correct answer reliably, meaning that it detects a particular genetic variant when it is present and does not detect the variant when it is absent. A test’s accuracy is referred to as “analytic validity.” Further, there must be adequate scientific evidence to support the correlation between the genetic variant and a particular health condition or risk—the so-called clinical validity.
Currently, the federal government exercises limited oversight of the analytic validity of genetic tests and virtually no oversight of their clinical validity.
Several complaints have been filed and are pending with the FTC about a specific DTC genetic-testing company, and the FTC recently issued a consumer alert warning the public that “some of these [DTC] tests lack scientific validity, and others provide medical results that are meaningful only in the context of a full medical evaluation.”
So there in lies the problem. They have several solutions.
Recommendations I. Transparency To promote transparency and to permit providers and consumers to make informed decisions about DTC genetic testing, companies must provide all relevant information about offered tests in a readily accessible and understandable manner.
a. Companies offering DTC genetic testing should disclose the sensitivity, specificity, and predictive value of the test, and the populations for which this information is known, in a readily understandable and accessible fashion.
b. Companies offering DTC testing should disclose the strength of scientific evidence on which any claims of benefit are based, as well as any limitations to the claimed benefits. For example, if a disease or condition may be caused by many factors, including the presence of a particular genetic variant, the company should disclose that other factors may cause the condition and that absence of the variant does not mean the patient is not at risk for the disease.
c. Companies offering DTC testing should clearly disclose all risks associated with testing, including psychological risks and risks to family members.
d. Companies offering DTC testing should disclose the CLIA certification status of the laboratory performing the genetic testing.
e. Companies offering DTC testing should maintain the privacy of all genetic information and disclose their privacy policies, including whether they comply with HIPAA.
f. Companies offering DTC testing and making lifestyle, nutritional, pharmacologic, or other treatment recommendations on the basis of the results of those tests should disclose the clinical evidence for and against the efficacy of such interventions, with respect to those specific recommendations and indications.
The Sherpa Says:
I am still waiting for the data from Salugen/Luxor...........hmmm I wonder why? Wake up people, this field is filled with snake oil salesmen!!!!