Direct-to-Consumer Genetic Testing: The Dollars are in the Database

Posted by Emily Stehr December 18, 2012
Biopolitical Times

2012 has seen more venture capital investment in genomics firms than any previous year. Two big deals went down in the genetic testing world just last week. Biotech mogul Amgen bought Iceland-based deCODE for $415 million, and 23andMe raised $50 million from a Russian internet billionaire, Google and other investors. These seemingly totally separate deals may actually be related; the former may give us insight into 23andMe’s true mission.

While deCODE made a brief foray into the direct to consumer (DTC) testing market with its 2007 deCODEme product, the company has been primarily focused on creating a “universal health database” of Icelanders, to be used by researchers, ever since its founding in 1996. The database and not the testing kit was what made the company appealing to Amgen, which has announced that it has no plans to continue the deCODEme service, which cost $1100 — far more than its direct competitor, the 23andMe DTC genetic testing kit. 

In 23andMe’s news release and much of the accompanying mainstream press coverage, CEO Anne Wojcicki emphasized that her company’s new capital would be used primarily to lower the test’s price to $99 (from $299) and thereby achieve the company’s goal of reaching one million users. Why is it so important to have a million users? In Wojcicki’s words, “By having 1 million individual users you can get to a scale where researchers are running data queries through 23andMe, where drug studies leverage our data, and where individuals can more easily be connected to studies that could benefit them.”

Whatever happened to the company’s original mission? That was to be a “leading personal genetics company dedicated to helping individuals understand their own genetic information through DNA analysis technologies and web-based interactive tools.” Now it seems the company’s real goal is to “create a [very valuable] data platform that can be easily searched and used by researchers all over the world.”

23andMe’s primary message is “own your own data,” but there’s a caveat: If a researcher does discover a miracle drug thanks to your genetic information, you do not own any portion of the resulting profit. Indeed, 23andMe already has a patent for genes associated with Parkinson’s. The Supreme Court may make that worthless when it rules in the Myriad case in a few months, but the principle of profit remains.

There is regrettable precedent here. Remember John Moore? Henrietta Lacks? Tissues from these patients generated enormous amounts of wealth but the patients themselves had no ownership, or say, in how their own bodies were used. 

But John Moore and Henrietta Lacks were unsuspecting victims of doctors who shirked their duty to obtain informed patient consent. Technically, 23andMe users cannot be; a whopping 90% of the 180,000 people who have thus far sent their DNA in to be analyzed have affirmatively opted to share their information with researchers. Similarly, the deCODE subjects were all entirely voluntary participants in the massive genetic project in Iceland. But even deCODE came under fire for — you guessed it — privacy concerns.

One reporter aptly noted, “As genetics testing becomes more common and the data passes through more hands, there’s an increased chance the data could accidentally leak out.” Although there is a federal law on genetic privacy and nondiscrimination, it does not protect against discrimination in the contexts of life insurance, disability insurance, or long-term care insurance. That is worrisome. As long as the federal government fails to extend the law, state legislatures are left to protect citizens who make themselves vulnerable in the name of medical advances, and so far the states have taken markedly different, and sometimes superficial, approaches.

It’s becoming increasingly apparent that the value of the DTC gene testing business is really in amassing and selling gigantic genetic information databases. Now that a private company is poised to take the game to a new level, it’s past time for our representatives to flesh out the rules. If 23andMe is going to play hardball, all of us who wish to see medicine capitalize on genetic understanding deserve at least a helmet.

Previously on Biopolitical Times: