It's Back, 23andMe Relaunches Its Consumer Gene Test

The genetic testing service 23andMe has relaunched a controversial test that, using just a few drops of spit, can tell you if you're a carrier for dozens of diseases.

It's not as extensive as its previous service, which could screen for hundreds of health risks, but the new modified test is approved by federal regulators, clearing a major hurdle that had placed the company's future in doubt.

In November of 2013, the startup was hit with a warning letter from the Food and Drug Administration, ordering the company to stop selling and marketing its personal genome service, which tested for risks associated with diseases like breast cancer and Parkinson's Disease. While the company pondered how to prove the accuracy of its product to the FDA's satisfaction, 23andMe stripped down its genetic test to only deliver raw genetic data and ancestry information. The sales of its testing kits dropped.

"We didn't understand the implications of that letter," said 23andMe's president Andy Page, in an interview earlier this week. "We needed to hire a lot of people to get us back on track."

Since then, 23andMe has worked closely with regulators to bring its full test back to market. Earlier this year, the FDA approved its carrier test for Bloom Syndrome, a rare disease associated with short stature and a higher cancer risk. At the time the FDA said it would not review other such carrier screening tests, clearing the way for the company to resume offering some health information.

Earlier this week, the company walked me through its redesigned product, which is available for $199. 23andMe bills this test as a major improvement on its previous efforts, despite that its roster of health tests is limited. It still doesn't include carrier tests for hereditary breast and ovarian cancer, as well as tests for drug responses and adverse drug reactions. Prior to the regulatory crackdown, 23andMe included these tests and more.

That said, the new website is better-designed and easier to navigate. The team clearly spent a lot of time replacing scientific jargon with conversational language to avoid confusion. This may well be a response to the FDA's concerns that people will misinterpret their results and take drastic steps, such as an unnecessary test or procedure.

23andMe also includes plenty of fun facts that are perfect for dinner party conversation, like the underlying genetic reason that you might be annoyed by the sound of other people chewing. Ancestry is still a major focus for the new test: You can now share and compare your genetic variants with other family-members and access a detailed report on your ethnicity.

More Than Just a Test 

Only time will tell whether the new product will prove as compelling as 23andMe's original test. For one thing it is more expensive: The previous price point was $99.

People who take the test can opt in to clinical studies and research. Those who consent will receive the occasional survey question and an offer to join a clinical trial, according to Page. In the past few years, 23andMe has inked partnerships with a variety of pharmaceutical companies including Pfizer. According to 23andMe's privacy policy, these partners can only access your health data with your consent (with the possible exception of law enforcement.)

23andMe may have made a name for itself with its DNA test, but it is doing a lot of medical research behind the scenes. Given its vast store of patient data -- 1 million customers and counting -- the company is well poised to develop new medications. Page said 23andMe plans to spend some of the $115 million it recently raised on two new labs: one for the therapeutics team to experiment with new drugs, and the other to develop more sophisticated gene-sequencing techniques.

Page declined to comment on whether 23andMe plans to offer more sophisticated DNA sequencing in the future. At present, it offers genotyping, which looks at genetic variants but not the exact sequence of a length of DNA. Sequencing technology has drastically come down in price in the past decade -- you can now sequence your whole genome for $1000 -- but it is still far more expensive than 23andMe's genotyping test.

The path forward for genetic testing? 

23andMe is just one of a growing number of tests on the market that offer genealogical, health and wellness reports. But what's unique about its test is that the genetic test results are delivered directly to you, rather than through your doctor. Counsyl, another DNA testing service that is popular with would-be parents, requires a doctor's note.

The FDA targeted 23andMe for its direct to consumer approach. But the company has not bowed to pressure from its critics. 23andMe's CEO Anne Wojciki told me recently that she is committed to sharing health data directly with consumers, even if it means years of paperwork: "I’ve said many times that consumers with no background in medicine can understand complicated ideas."

But some health experts harbor mixed feelings about whether this is the safest approach.

Bob Wachter, interim chair of the department of medicine at UCSF, said he was glad the FDA stepped in when it did. But he does believe that 23andMe's approach is the future, especially if they can find a way to work with regulators.

"The pressure over time will be that more health information is available directly to the consumer" he said. "But this needs to be tapped periodically to make sure it doesn't get ahead of itself."