Posted On: December 2, 2013 by Patrick A. Malone

FDA Tells Genetic Testing Service to Stop Marketing Misinformation

Federal regulators are catching up to some warnings we and others issued a year ago about hype in the genetic testing industry.

We blogged about 23andMe, a company that offers genetic testing directly to consumers. We also devoted an issue of our newsletter to explaining how genetic testing works, and the implications for the medical consumer.

As we concluded then, genetic testing can be a valuable and useful tool for diagnosing and treating medical conditions. But it’s also a minefield for miscommunication, overtesting, overtreatment and emotional turmoil.

Last week, the FDA came down on 23andMe, the best known genetic testing outfit, ordering it to stop marketing its DNA sequencing service until further notice. The warning letter said there is no evidence that the company’s Personal Genome Service renders accurate results.

According to the letter, “FDA is concerned about the public health consequences of inaccurate results from the PGS device; the main purpose of compliance with FDA’s regulatory requirements is to ensure that the tests work.” The agency considers the Personal Genome Service a medical device, and those require FDA approval.

In 2010, according to the New York Times, the FDA sent letters to 23andMe and other genetic-testing operations explaining that regulatory approval would be required for the tests. As a result, some companies stopped offering them directly to consumers.

As The Times reports, 23andMe is run by the wife of Google co-founder Sergey Brin, and the Internet giant subsidizes it. It has about half a million customers, and its tests, among other things, purportedly handicap their risks of developing certain diseases, including diabetes, coronary heart disease, and breast cancer.

The last is of particular concern to the FDA, and the tests for the BRCA1 and BRCA2 genes, mutations of which indicate that a woman might have a high risk of getting breast or ovarian cancer. The feds are concerned that a false positive could cause a woman to undergo a needless mastectomy. That’s a viable, and often smart, option for some women, including Angelina Jolie earlier this year, but it’s a huge decision that shouldn’t be made on the basis of results via DNA-by-mail.

The FDA also expressed concern about 23andMe expanding into testing of genetic variants to help predict patient responses to drugs such as warfarin, a common blood-thinning medication.

23andMe applied for approval for some uses of the gene-sequencing test last year, but it failed to provide additional information the agency requested. The FDA considers that nonresponse a withdrawal of the application. It also called the company onto the carpet for “14 face-to-face or teleconference meetings, hundreds of email exchanges and dozens of written communications” since 2009.

“However,” the letter continues, “even after these many interactions with 23andMe, we still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses, which have expanded from the uses that the firm identified in its submissions.”

“Instead, we have become aware that you have initiated new marketing campaigns, including television commercials that, together with an increasing list of indications, show that you plan to expand the PGS's uses and consumer base without obtaining marketing authorization from FDA.”

As The Times reports, whether genetic tests require FDA approval and whether doctors must be involved in ordering them are the subjects of much discussion. 23andMe believes that consumers are entitled to the information on their own DNA; medical professionals and health policy watchdogs warn that without context and counseling, consumers can’t possibly understand all the implications of their test results.

Genetic testing companies aren’t just protecting your rights with their defense of direct-to-consumer services — they’re making money off them. 23andMe sells the testing service for $99. It also offers ancestry information, and, according to The Times, hopes to grow to 1 million customers by early next year. It plans to leverage all this juicy biomedical data into biomedical research, such as finding genetic causes of diseases.

That sounds noble. But can you really trust a company with your most intimate personal information if it's making money off your DNA, and the process to retrieve it demonstrates less than rigorous attention to safety?

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