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Clinical Laboratories and Pathology Groups

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GAO Gives Congress a Poor Report on Direct-to-Consumer Genetic Tests Sold by Web-Based Companies

According to the Wall Street Journal, Direct-to-consumer (DTC) genetic tests from the four companies 23andMe, Navigenics, deCODE genetics, and Pathway Genomics Corp, are generating results “that are misleading and of little or no practical use.”  This was the finding of the U.S. General Accounting Office (GAO) in its recently released report.

Pathologists and clinical laboratory managers will be interested to know that the GAO sent multiple specimens to these four companies—each of which is organized to sell genetic tests and molecular diagnostics directly to consumers via the Internet. The GAO determined that, even when given identical DNA samples, the tests from these four companies yielded contradictory results.

In order to assess whether the tests provided any medically useful information, GAO consulted with genetics experts on the results of the tests and the voracity of some of the claims being made by the companies’ representatives and their Web sites. Comments from GAO’s genetics experts ranged from “no scientific basis” to “absolute lies” to “complete garbage.”

The title of the GAO report on DTC genetic testing is: “Misleading Test Results Are Further Complicated by Deceptive Marketing and Other Questionable Practices.” The report pulls no punches and states:

  • GAO’s donors often received disease risk predictions that varied across the four companies, indicating that identical DNA samples yield contradictory results.
  • GAO’s donors also received DNA-based disease predictions that conflicted with their actual medical conditions.
  • None of the companies could provide GAO’s fictitious African-American and Asian donors with complete test results, but did not explicitly disclose this limitation prior to purchase.
  • Consultations offered by three of the companies failed to provide the expert advice that the companies promised.
  • Although the experts GAO spoke with believe that these tests show promise for the future, they agreed that consumers should not rely on any of the results at this time.

The GAO’s findings raise many questions about the accuracy and clinical relevance of the genetic tests offered to consumers by some Internet-based companies. The GAO noted the possibility that consumers could take inappropriate actions against their true needs based on the misleading information. One genetic expert told the GAO that, “The fact that different companies, using the same samples, predict different directions of risk is telling and is important. It shows that we are nowhere near really being able to interpret [such genetic tests].”

It appears that the FDA, HHS and Congress want to get ahead of the trend of selling direct-to-consumer genetic tests over the Internet. Pathologists and clinical laboratory managers should consider several things: First, government regulators are not likely to let an unregulated consumer marketplace in genetic testing develop on the Web. The GAO’s report is one early step that will probably lead to some form of regulation.

Second, the findings of the GAO provide evidence that the clinical accuracy and relevance of many genetic tests offered directly to consumers via the Internet and other DTC retail channels is questionable.

Third, the fact that Congress is spending time on this issue means that consumer demand for direct access to genetic tests continues to grow. It would seem that established clinical laboratories have a natural advantage to offer consumers a select number of clinically accepted genetic tests along with helping those consumers get appropriate genetic counseling and patient education about the text results.

Related Information:

Hearing on “Direct-To-Consumer Genetic Testing and the Consequences to the Public Health”

Committee Requests Additional Information Regarding DNA Processing Errors

Committee Investigates Personal Genetic Testing Kits

FDA to Hold July Public Meeting on LDT Oversight

Update on Congressional Hearing on Direct-To-Consumer Genetic Testing (23andMe)

Direct-To-Consumer Genetic Tests: Misleading Test Results Are Further Complicated by Deceptive Marketing and Other Questionable Practices