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In addition to helping people avoid side effects, the AmpliChip might save lives. Some older antidepressants, for example, can cause cardiovascular problems if ingested in high enough doses. And while most drugs are administered in their therapeutically active form, some drugs, such as the breast cancer drug tamoxifen, must be metabolized to be effective, so they may fail to work in poor metabolizers.

“Adverse [drug] events cost the ­public-­health system one to two billion dollars per year,” says Lawrence Lesko, director of the Office of Clinical Pharmacology at the FDA. “One of the [results] is going to be prospective use of devices like AmpliChip.” He adds that in the future, doctors or pharmaceutical companies could be held liable if a patient is not given a genetic test and experiences serious side effects. “I think we’re going to see a huge consumer interest in pharmacogenomics,” says Lesko. “And I think we’re going to see more tests.”

Comical Confusion

Maybe. But it’s clear that the consumer boom has not yet begun. For routine blood tests such as those for high cholesterol or anemia, you stroll to a lab down the hall from the doctor’s office, surrender some blood, and get a call with the results a few days later. But as I quickly learned, the sheer novelty of the AmpliChip test makes matters far more difficult. For one thing, the test is enormously expensive–I paid $1,360, though prices vary depending on the lab–and is not covered by most insurance companies. And many doctors are unfamiliar with the test and may be reluctant to order it. When I asked my doctor to have me tested, he quickly dismissed the idea. He had never heard of the test; besides, he told me, he could figure out my optimal dose of various drugs the old-fashioned way, by trial and error.

When I finally got the opportunity to take the test (thanks to a new doctor and a subsidy from Technology Review), I encountered an almost comical level of confusion. Though my new, younger physician was more open to the idea, I was the first of her patients to ask about the AmpliChip, and she had no idea how to order it. I found prescribing directions on the Roche website, and a list of the few labs in the country that actually offer the test. When I called the closest one of them, a 20-minute drive from Boston, the person on the other end of the phone said she didn’t know what I was talking about and hung up.

Calls to both Roche and the lab’s headquarters resolved the confusion, and a few days later I arrived at a medical strip mall with a prescription from my doctor and specific instructions for the phlebotomist–“Tell her to draw seven milliliters of blood into a lavender-top tube and store it at room temperature”–lest the confusion persist. When I asked the phlebotomist how long I would have to wait in order to get the results, she replied that she had no idea. I was her first patient to get the test.

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Tagged: Biomedicine

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