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INDUSTRY NEWS

Gordon H. Smith

If Senator Gordon H. Smith (D–OR) could have it his way, selling direct-to-consumer (DTC) genetic tests in the United States will become more difficult in the near future. Responding to growing concerns about the lack of oversight of such DTC tests and the unproven science behind them, Senator Smith, who is chairman of the Senate Special Committee on Aging, called for a yearlong investigation by the Government Accountability Office (GAO) into companies that are selling DTC genetic tests.

At a recent hearing held by the Special Committee on Aging, GAO presented the findings of its investigation. During the past year, GAO purchased tests from four Web sites and created fictitious consumers by submitting DNA samples for analysis. According to GAO’s report, “The results from all the tests purchased mislead consumers by making predictions that are medically unproven and so ambiguous that they do not provide meaningful information to consumers.”

“I am deeply disturbed by GAO’s finding that consumers are being misled and exploited by this modern-day snake oil,” said Senator Smith in his opening statement at the hearing. “And I am shocked to learn how little the federal government is doing to help consumers make informed decisions about the legitimacy of these tests.”

As a result of GAO’s findings, Senator Smith and the committee have been exploring ways to improve the regulation of DTC genetic tests and to warn consumers about such tests.

“The senator is looking at the current gaps in the regulations of genetic testing and the threat that it has to public health,” said Kimberly Collins, a spokesperson for the Special Committee on Aging. “Since the hearing, Senator Smith has continued to work with FDA and CMS to look into the safety and efficacy of these laboratory tests.”

In addition, on the day of the hearing, Senator Smith announced that the Federal Trade Commission, in conjunction with FDA and CMS, released an alert cautioning consumers about DTC genetic tests.

Tightening the regulation of DTC genetic tests would be a welcome change and a vast improvement over the current situation. As GAO’s report pointed out, since there is no genetic testing specialty under CLIA, there are no specific requirements or unique standards for laboratories that perform genetic tests. Such minimal oversight makes it difficult for consumers to determine whether a genetic test provides meaningful, scientifically based information.

“There’s still more that needs to be done to ensure that there’s adequate regulation by FDA of home-brew laboratory tests,” said Collins. “The senator is still considering different options to ensure that there is such adequate regulation. The senator is in communication with FDA and CMS to see what needs to be done to ensure the safety of consumers. He’s also looking at whether a legislative option is needed or if there needs to be a genetic test specialty under CLIA.”

Industry analysts agreed with the senator’s assertions that the regulations for DTC genetic tests need to be changed, which is long overdue.

“If a DTC genetic test has not been cleared or approved by FDA, the test should not be made available without a physician’s order and physician interpretation,” said Glen P. Freiberg, president of RQC Consulting (San Diego). “At the same time, a laboratory-developed test that is ordered by a physician may still not have test-to-test, lot-to-lot, or lab-to-lab reproducibility. The CLIA rules don’t do enough to ensure this. Consequently, an update to the regulations is required that treats all tests in the same way, requiring manufacturing reproducibility, test reproducibility between labs via proficiency, and a determination of clinical utility by a physician or lab, not the government.”

A copy of the report can be accessed via the GAO’s Web site at www.gao.gov/new.items/d06977t.pdf. Additional information can be accessed via the Senate Special Committee on Aging’s Web site at http://aging.senate.gov/public/.