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GAO Report Critical of Genetic Tests Marketed to Consumers
FDA Working to Regulate Products
By News Staff
The GAO had testified during a 2006 hearing that some direct-to-consumer genetic tests make medically unproven disease predictions. Congress then asked the GAO to investigate products on the market and the methods used to market them.
In response, the GAO purchased a total of 40 such tests, ranging in cost from $299 to $999, from four different companies. Investigators then selected five donors and sent two DNA samples from each donor -- one using factual information about the donor and one using fabricated information -- to each test company for evaluation.
"Each donor's factual profile received disease risk predictions that varied across all four companies, indicating that identical DNA can yield contradictory results depending solely on the company it was sent to for analysis," Kutz testified in last month's hearing. "These risk predictions often conflicted with the donors' factual illnesses and family medical histories."
Investigators found 10 "egregious examples of deceptive marketing," including claims made by the four companies that a customer's DNA could be used to make personalized supplements capable of curing diseases.
Kutz said two of the companies recommended expensive dietary supplements that actually were "inexpensive multivitamins available at any drug store."
Jeff Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health, testified that the FDA has approved several genetic tests since 2003, but he said none of the tests marketed directly to consumers have been subject to premarket review by the agency.
Shuren said there are two ways for genetic tests used in clinical management of patients to reach the marketplace. One is for a manufacturer to develop a commercial test kit that can be distributed to multiple laboratories. He said the agency has approved several tests for specific genetic factors.
The second path is through the development of a test by a laboratory for use only by that lab. Shuren said there are as many as 5,000 such laboratory-developed tests on the market, and hundreds of different laboratories offer them.
Shuren added that the FDA has observed numerous problems with such tests and their marketing in recent years, including the presentation of fraudulent data, faulty data analysis, exaggerated clinical claims, poor clinical study design and unacceptable clinical performance.
"These tests have not been proven safe, effective or accurate," Shuren said, "and patients could be put at risk by making medical decisions based on data that has not received independent premarket review."
Shuren said the FDA is working to regulate genetic tests to "give patients and doctors confidence in these tests and facilitate progress in personalized medicine."
The FDA intervened earlier this year when Pathway Genomics Corp. announced that its Pathway Genomics Genetic Health Report would be available directly to consumers through Walgreens stores. The agency sent notice to the manufacturer that the FDA had not approved its product.
Since that time, the FDA has contacted more than a dozen other companies that market tests directly to consumers.
According to Shuren, more than 350 U.S. laboratories have voluntarily listed themselves on a website that provides information about labs offering genetic tests, but he estimated that the actual number of labs that offer such tests may be twice that figure.
Policy on Home Test Kits
Policy on Direct-to-Consumer Advertising of Prescription Pharmaceuticals, Nonprescription Medications, Health Care Devices, and Health-related Products and Services
American Family Physician: Letters to the Editor: "Family History and Genetic Testing for Cancer Risk"
(April 15, 2010)
American Family Physician: "Assessing Breast Cancer Risk in Women"
(Dec. 15, 2008)
U.S. Government Accountability Office: "Direct-to-Consumer Genetic Tests: Misleading Test Results Are Further Complicated by Deceptive Marketing and Other Questionable Practices"
Pathway Genomics Corp. Press Statement in Response to the GAO Report