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Anne

December 9, 2014 -- I have lots of heroes. My newest is Anne Wojcicki, one of the panelists at the Technology Advisory Group meeting I attended today. She is the co-founder and CEO of 23andMe, the company that, for $99, will sequence your DNA from a saliva sample and would (if it were permitted) tell you a lot about your genetics, your ancestry, and predispositions for a variety of traits and conditions.

Alas, the FDA shut them down citing the potential for inaccurate results. The main problem is a regulatory system that cannot keep pace with innovation. By definition, regulators are a step behind and in cases like this one it is to our detriment. We do need regulation to keep us safe from snake oil but the delicate balance between that and new technology sometimes eludes us. As Ms. Wojcicki explained it, each of the genes for which her company tests is considered by FDA rules to be a distinct diagnostic product. 23andMe would have had to apply for literally millions of product licenses. Instead they went belly-up.

When it was still in business, 23andMe sold a commoditized version of the precision medicine Sam Hawgood (see below) talked about. Indeed, Ms. Wojcicki's vision was to liberate genetics from the research lab and create a consumer revolution. "Who owns the data?" she asked. This would have enabled us each to possess our own.

Another obstacle was the all too familiar one of reimbursements. Though genetic information has the potential to make health care more effective, insurers will not reimburse for tests like these. Like the regulators, they are behind the times and the quality of our health outcomes suffers as a result. Ms. Wojcicki quoted an MD at a conference: "The biggest problem with 23andMe is you generate non-billable questions."

How do we get regulation and reimbursement to catch up with technology and with the public good? Perhaps nobody knows the complete answer but some good people are working on it. Go Anne!

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