Unregulated at-home DNA test kits are being marketed directly to consumers over the Internet. Consumers fill out a lifestyle questionnaire and send samples of their DNA (from a cheek swab) to the company. The companies claim to analyze the consumer's genetic code, sending the results to the consumer along with nutritional supplement, diet, and health advice. Now a report by the Government Accountability Office (GAO) has found that home DNA tests are misleading to consumers. The U.S. Food and Drug Administration (FDA) has issued a consumer alert warning that the tests lack scientific validity.
The report, presented at a July, 2006 hearing held by the Senate Special Committee on Aging, investigated DNA home tests from companies that claim to analyze a person's DNA and offer health and diet advice based on the analysis. Researchers from the GAO tested home DNA kits from four companies, Suracell (New Jersey), Genelex (Seattle), Sciona (Colorado), and Market America (North Carolina). They created 14 fictitious consumers using DNA samples from the same two subjects, a nine-month old female and a 48-year-old male. This was submitted to the companies for analysis along with 14 fictitious questionnaires.
The researchers found that the companies' health advice and warnings of genetically predisposed diseases differed for the fictitious consumers, although they had the same DNA. Findings also revealed that the companies offered supplements at an exorbitant cost, supposedly customized to the consumer's DNA. The GAO found that the expensive supplements were almost identical to inexpensive generic vitamins.
At this time, there is no legislation regulating the at-home genetic testing industry. "Genetic testing is growing rapidly and holds great promise to improve health and healthcare," says Dr. Kathy Hudson, director of the Genetics and Public Policy Center. "The information provided by genetic tests is used to make profound, sometimes life-and-death, decisions. It is therefore imperative that this information be accurate and reliable and relevant to a patient's health."
REFERENCES:
1. McDermott L. Consumers warned on home DNA tests. ScienceDaily, July 28, 2006.
Posted by Elaine Gavalas on October 11, 2006 02:23 PM
