Monday, February 3, 2014

Should the FDA Take a More Libertarian Stance Towards Personal Genomics?

Geneticists, lawyers, students and industry experts packed into a conference room on Stanford's campus this week to discuss the ethics behind the FDA's decision to effectively shut down the health assessment element of the world's leading direct-to-consumer genome analyzer, 23andMe.

"We're here to talk about why the FDA dropped the anvil on 23andMe," said Stanford Law School professor Hank Greely, a mustachioed man in a Cosby sweater who led the session. "Rules for consumer genomics have been up in the air for some time. Some of us have been calling for regulations for about a decade now."

The promise of 23andMe is informing participants whether they have a mutation that makes them more susceptible to a certain disease. The company mails customers “spit kits” and then analyzes people’s DNA via their mailed-in saliva sample.

In November, the FDA issued 23andMe a warning to stop marketing its $99 in-home DNA collection spit kits, the most common means of consumer genome analysis in the US. The agency wants to ensure that the kits and tests performed in 23andMe's lab are scientific and accurate in assessing disease risks. It's unclear how, exactly, that process is unfolding.

Presumably, the FDA has asked 23andMe for proof of the validity of its tests, but the agency hasn't said, so we don't really know. Meanwhile, 23andMe has continually dragged its heels in responding to the FDA's requests, as Motherboard's Grace Wyler detailed last month.

"The FDA is working on something—guidance or clearance," Greely said, "but it's not really clear what."

The 23andMe kerfluffle is of particular interest to academics at Stanford, which was ranked No. 1 among universities in genomics by US News & World Report. The outcome will likely shape the parameters of a field that is emerging as a cornerstone of the personalized health care movement.

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