When personal genomics and biotech firm 23andMe was founded in Mountain View, Calif., in 2006, the hype over the genetic tests it offered directly to consumers was immediate and irresistible to many. The company promised that for a nominal fee, it could scan your saliva sample and tell you based on your genetics everything from who your ancestors were to what diseases you may be at risk of developing many years down the road. 23andMe raised more than $100 million in capital from such big-name investors as Google and Genentech. Today, the companys website boasts having close to 500,000 genotyped consumers.

So it was a surprise to some observers when, on November 22, the U.S. Food & Drug Administration (FDA) sent a strongly worded letter to 23andMe CEO Anne Wojcicki demanding that the company stop marketing its test, called Personal Genome Service (PGS), until it secures authorization from the agency. The FDA contends that PGS is a medical device being pitched for the diagnosis and prevention of disease, and therefore it must obtain approval under federal law.

Whenever regulators step in and try to yank a product off the market particularly when the company selling it is already well entrenched it invariably sparks a debate about whether over-regulation will stifle technology innovation. However, some experts believe the real issue at stake in the 23andMe controversy is not innovation, but rather the firms selling strategy. I suspect that a lot of this boils down to the way 23andMe has been marketing itself. It has taken a pretty aggressive stance in saying its services have a medical benefit, notes Reed Pyeritz, professor of medicine and chief of the division of medical genetics at the Perelman School of Medicine at the University of Pennsylvania. That does get the attention of the FDA.

Indeed, as the FDA pointed out in its letter, PGS promised to provide information on 254 health conditions, including heart disease, diabetes and breast cancer. 23andMe offered complete reports along with the test results, with advice on genetic susceptibility, potential response to particular drugs and preventative steps customers might take to protect their health. Most of the intended uses for PGS listed on your website, a list that has grown over time, are medical device uses, the warning letter says.

The understanding of the human genome is still in its infancy, and in most cases, genetic susceptibility to a disease does not translate into a definitive risk of developing that condition. The FDA expressed concern that 23andMes customers would take drastic measures to prevent diseases without fully understanding what their genetic results truly prove about their risks. The worries are well-founded because who knows what individuals will do with information that they interpret themselves? Pyeritz says. Very few genetic tests actually have been studied for clinical utility. Had 23andMe been marketing things more truthfully, I wonder if they would have ever gotten this warning letter from the FDA.

I suspect that a lot of this boils down to the way 23andMe has been marketing itself. It has taken a pretty aggressive stance in saying its services have a medical benefit. Reed Pyeritz

23andMe continues to sell PGS; however, it is only offering ancestry information and raw genetic data without any interpretation, a spokeswoman for the company told Knowledge@Wharton in an e-mail. Our goal is to work with the FDA in a way that clearly demonstrates the benefit to people and the validity of the science that underlies the test, she wrote, adding that the company intends to complete the regulatory review process.

Recreational Genetics

Just how useful are genetic tests marketed directly to consumers? Pyeritz has undertaken a few studies designed to answer that question. One set of studies, done in conjunction with the Coriell Institute for Medical Research in Camden, N.J., set out to determine the demographics of people who seek out direct-to-consumer genetic tests. The researchers discovered that most customers are Caucasian, well educated and economically upscale exactly what they expected for a product that could be considered recreational genetics, Pyeritz says.

Beyond that, we asked them what they intended to do with the information, he notes. The majority said, Were going to give it to our physicians.

Original post:
The FDA vs. 23andMe: A Lesson for Health Care Entrepreneurs

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