FDA Panel Says Home Gene Tests Need Doctor Input

VIDEO: Childrens Memorial Hermann Hospitals Dr. Hope Northrup says tests arent ready
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GAITHERSBURG, Md. -- Certain types of genetic tests that are available for at-home use without a prescription should not be used without the involvement of a physician or genetic specialist, an FDA advisory panel recommended.

So-called direct-to-consumer (DTC) genetic tests can provide information ranging from a whether a person is lactose intolerant, at risk of developing Alzheimer's disease, or likely to respond to a certain type of drug. After taking a quick blood or saliva sample in the privacy of one's own home, the test is mailed to a laboratory for interpretation and the person is later sent his or her results.

But some of those results -- for example, a person's likelihood of developing heart disease -- are of limited utility without the involvement of a physician, agreed members of the FDA's Molecular and Clinical Genetics Advisory Panel, which wrapped up a two-day meeting on DTC testing on Wednesday afternoon.

Read this story on www.medpagetoday.com.

"I want any test that has a high predictor that a person will get a disease, I want that filtered through a physician," said panelist Dr. Valerie Ng, a pathologist at the University of San Francisco in Oakland, Calif.

The panel wasn't clear on whether that would mean a physician would have to order the test, or if a physician would have to interpret the test, or both. That will ultimately be up the FDA to decide. The agency -- which may decide to make certain tests that are currently DTC available by prescription only -- isn't required to follow the advice of its advisory committees, but it often does.

Physician involvement is not nearly as important for nutrogenetic tests that tell a person how their body processes a certain type of food, or for other less-serious genetic information, such as whether the person has thick earwax, the panel decided.

Following the hearing, Alberto Gutierrez, director of the FDA's Office of In Vitro Diagnostics, told reporters that certain types of tests, such as nutrogenetic tests, might be appropriate for at-home use as long as the companies make truthful claims.

Home Tests Need Doctor Involvement

Other tests, such as carrier screening tests -- which show whether a person is a genetic carrier of a condition and therefore has a risk of passing it on to their children -- may eventually require doctor involvement.

"We're not going to be able to take one approach to all types of tests," Gutierrez said. "Some may not require a doctor at all and some might require that a qualified health professional be involved, and some might involve the doctor to order the test."

"Most of the committee agrees that physician involvement is necessary," panel chairman John Waterson, MD, PhD, a geneticist at Children's Hospital and Research Center in Oakland, Calif., told MedPage Today after the meeting.

The popularity of DTC tests increased exponentially following the completion of the Human Genome Project. Last year, the FDA informed companies selling the do-it-yourself genetic tests that they weren't in compliance with FDA regulations. That move led pharmacy giant Walgreens to shelve plans to stock a genome mapping kit. Some companies dropped out of the DTC game, and others have been working with the FDA to comply.

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