Personal Gene Tests May Need Restrictions, FDA Official Says

Some genetic tests sold directly to consumers as predictors of health risks may instead need to be supplied through doctors, a U.S. Food and Drug Administration official said.

The agency will decide, case-by-case, whether to restrict the availability of tests sold by companies such as 23andMe Inc., Alberto Gutierrez, director of the FDA office that regulates diagnostic screening tools, said today after an advisory panel meeting.

The test kits allow consumers to collect saliva samples and send them to the companies for DNA analysis. The FDA said last year that home gene-testing kits may require the agency’s approval if they make health claims. The FDA called the two-day advisory panel meeting to obtain guidance on how to regulate the products to ensure their benefits outweigh potential risks.

“We’re probably not going to be able to take one approach to all the types of tests that the companies want to offer,” Gutierrez told reporters. “It depends on the disease and the type of test.”

The FDA may require some tests to be ordered by doctors, and some results may have to be sent to doctors instead of patients, he said. Other gene tests “may not require a doctor at all,” he said.

Do-it-yourself gene analysis may do more harm than good if people use them to predict medical risks without consulting their doctors, members of the panel said today. Consumers may make the wrong health choices if they misinterpret the results of the tests, panel members said.

Working on Compliance

Executives from Mountain View, California-based 23andMe and Pathway Genomics Corp., both closely held, said they are working with the FDA to bring their gene tests into compliance with agency rules. Walgreen Co., the largest U.S. drugstore chain, halted plans last year to carry gene tests made by San Diego-based Pathway after regulators said the kits appeared to be medical devices subject to agency review.

Pathway has voluntarily stopped selling its gene tests to consumers while it works with the agency, Ed MacBean, the company’s vice president for product management, said today in a presentation to the panel.

“People have a right to their own health information,” MacBean said. Providing that information “can help consumers improve their own health and wellness while lowering the costs of health care.”

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