Daniela Hernandez/FUSION

For the first time in almost two years, the government is allowing genetics company 23andMe to tell its customers what's wrong with their DNA. Starting Wednesday, the company is reviving its genetic health report, which gives consumers information about whether they are genetic disease carriers.

Until suspended by the government for further testing, access to genetic health data was 23andMe's greatest promise to the world (and investors). It signaled a future in which your health information is yours, not the healthcare system's, to own.

That future was put on hold in November 2013, when the U.S. Food and Drug Administration, the agency that regulates medical tests, drugs and devices, slapped 23andMe with a cease-and-desist letter ordering it to stop marketing its spit-box genetic test as a health report. The move reduced the Silicon Valley startup to little more than a glorified ancestry service.

“We’ve worked with the FDA for nearly two years to establish a regulatory path for direct-to-consumer genetic testing,” said 23andMe co-founder and CEO Anne Wojcicki in a statement. “This is an incredibly dynamic time in genetics and we’re excited to be at the leading edge of bringing genetics directly to individuals."


Previously, the test gave you much more information about what your genetics might mean, such as your likelihood of developing breast cancer, strokes and brain aneurysms, sometimes based on what experts considered preliminary research. Here was my redacted results from the old test, for example:

My redacted 23andMe results from 2012, before the FDA limited the information 23andMe could provide consumers.


The new version of the test, which costs $199, is a pared down version of 23andMe's pre-November 2013 offerings, focused on more well-understood autosomal recessive disorders. It tells you about your "carrier status"—whether you've got the faulty genes associated with cystic fibrosis, sickle cell anemia, Tay-Sachs and 33 other autosomal recessive disorders.

In February, the FDA ruled genetic tests for these types of conditions don't need to be reviewed because the underpinning biology is so clearcut. If you have two copies of the faulty gene associated with one of these conditions, you're sure to develop it. If you only have one, you're safe.


The immediate benefit, then, is less about knowing what illnesses you might develop, and more about what conditions you might pass on to your children. For instance, if you and your partner both test positive for the faulty gene that causes Tay-Sachs or cystic fibrosis, your kids have a high probability—25% to be exact—of developing the disease. If only one of you carries this "bad" gene, the probably is 0.



23andMe hopes to bring back DNA-based risk prediction but it still needs FDA approval—and how long that will take is still TBD. Though its market is growing abroad, where regulations are more lax and they can provide more information, 85% of 23andMe's customer base is still in the U.S., so the Google-backed startup still needs to play nice with the feds.

"Part of the clearance from the FDA required that the average person could understand what we were reporting," said Brad Kittredge, 23andMe's vice president of product. To do that, the company conducted testing across the U.S. to figure out how best to present complicated genetic concepts in accessible an accessible way.


The new test is a stripped down version of 23andMe's original report with prettier packaging. The question now is whether it will draw in more customers. Nearly a decade after 23andMe was founded it's still not profitable. That could be due, in part, to the FDA letter. In the wake of the ruling, the rate of new signups for the service dropped by more than half, Wojcicki told the New York Times.

While it was once the clear leader in the direct-to-consumers genetics game, it's now got an unlikely formidable competitor in genealogy site Ancestry.com.


The Utah-based company has more than 1 million subscribers on its DNA service, AncestryDNA—rivaling 23andMe's once dominant database. It's not currently providing consumers with any health reports, but its hired a slew of medical and regulatory experts to help it deal with the FDA. In July, Ancestry launched a product dubbed AncestryHealth, which aims to collect self-reported health information from its users. That will undoubtedly hook into its AncestryDNA service in the future. It's hard not to see that as strategy to amass the kind of health-related information 23andMe has collected through surveys and questionnaires for years. Like 23andMe, Ancestry is hawking its database to partners like life-extension company Calico, which plans to use insights drawn from Ancestry's databank about the biological underpinnings of a long life to develop medications that recreate that font of youth for other people. As I wrote earlier this year:

"Ancestry.com’s huge advantage over services like 23andMe is its age; since it has been collecting ancestral data about its users for decades, it knows health information not just about its users, but about their great-grandparents and great-great-grandparents. That information, coupled with surveys and modern-day genetic testing, can inform users of any hereditary conditions that run in their family, and help them project health problems in their future"


23andMe also has to worry about bigger players, like IBM and its supercomputer Watson. IBM has been on a health company buying spree lately. In April, it acquired Explorys, a company spun out of the Cleveland Clinic with access to the anonymized health records of some 50 million people, for an undisclosed sum. In May, it snagged Phytel, which has access population health management data. Then in August, it bought Merge Health, owner of millions of medical images. It's also has partnerships with companies and academic institutions with access to a lot of genetic information, both from humans and their tumors. All of that is being fed into Watson, which is being trained by some of the best artificial intelligence experts in the world. "Big Blue" could be sitting on one of the largest, most comprehensive health and genetic databases in the world.

IBM has access to information neither 23andMe nor Ancestry.com have right now: full genomes and medical records, and that could give it an insurmountable advantage. "Having data, having statistics around people like you and what the outcomes are is very reassuring," said David Kelly, IBM's vice president for Senior solutions portfolio and research at a recent event in San Francisco. (Both consumer DNA services, only look at snippets of your DNA currently. They'd have to go back and sequence their million or so samples.) That could make IBM's database potentially more attractive to pharmaceutical companies than 23andMe and Ancestry.


Against this backdrop. 23andMe's database looks puny. All this means that the company has a steep road ahead. Drug discovery is a risky enterprise, where success rate is in the single digits. And right now, 23andMe, unlike IBM or Ancestry, doesn't have a backup business model. So it can't afford to fail.

Daniela Hernandez is a senior writer at Fusion. She likes science, robots, pugs, and coffee.