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DTC Genetic Testing, One Way or Another

At MIT Technology Review this week Antonio Regalado breaks open the not-so-secret loophole allowing customers to circumvent the FDA's crackdown on 23andMe by using outside interpretation companies, like Promethease, to decode their raw genetic data.

According to Regalado, growing use of these interpretation services (Promethease spits out between 50 and 500 gene reports a day) raises the question of whether such companies, especially larger ones, will become the next targets for FDA oversight.

Promethease's service compares customers' DNA data with entries in SNPedia, a public genomic database covering more than 50,000 SNPs that the company's founders Greg Lennon and Mike Cariaso created and run with a support staff of volunteers.

The FDA told MIT's Regalado that it has the authority to regulate software that interprets genomes, even free, wiki-style curation and translation programs. Earlier this year, the FDA's director of personalized medicine Elizabeth Mansfield made a similar statement, telling GenomeWeb that the FDA does consider such services to be medical devices, and thus are under the administration's regulatory reach.

According to Regalado, Promethease's founders dispute the idea that they fall under the FDA's discretion, and while the FDA has a wide authority, he says, it often chooses to ignore "small-time operators that bend the rules, especially if they avoid making overt health claims."

"But," he writes, "Cariaso and Lennon can't say they didn't anticipate trouble. After all, they named their software after Prometheus, the titan who defied the gods by stealing fire from Mt. Olympus and giving it to mankind."