Almost two years after it was ordered to stop selling its DNA analysis service by the US Food and Drug Administration, genetic testing company 23andme is set to announce that it will once again provide its customers with health data, The New York Times reports. The company will now be able to offer users information about their "carrier status," informing them of the risk of passing 36 diseases and conditions (including sickle-cell anemia and cystic fybrosis) on to their children, based on samples of their saliva.
The test shows diseases you may pass to children
The ban on selling its DNA testing product in November 2013 hit 23andme hard — CEO Anne Wojicki says new user signups dropped by half — but the company has worked with the FDA to come back to the market. Earlier this year, the FDA granted the company approval to start offering a limited test for the markers of rare genetic condition Bloom Syndrome, a sign seen as one of the first steps on the road to approval. The company has also diversified in the wake of the ban on its DNA testing service. Earlier this year it indicated that it would move into creating drugs, using its expertise to either work on its own, or partner with pharmaceutical companies to run trials.
While today's development marks a turning point in the long-running struggle between 23andme and the FDA, the company still won't be able to give customers the same range of health information as it could previously. The company twice submitted its health testing kit — which it claimed could identify up to 254 diseases and medical conditions from a sample of a person's saliva — to the FDA for review as a medical device, but the governmental body rejected the product in November 2013, arguing that users could face health issues from false positive or false positive assessments.
23andme is now worth $1.1 billion after its latest investment round
The new test is more limited in scope than the full-scale testing service previously offered, being focused on people who want to have children, but Wojicki says 23andme is now "working from within the system and saying the consumer will have a sense of ownership and a voice in that system." The company is still growing, riding a wave of interest that saw it tip over one million users this year, and score another $115 million in venture capital funding. 23andme has now notched up $241 million in investment, with $3.9 million of that coming from Google, bringing it to a valuation of $1.1 billion. The testing kit it will offer will also be raised in price, from $99 before it was banned by the FDA, to $199 for the new and more limited version.
But if the FDA does rule that it can sell a full-scale testing kit, it likely won't be the only one available on the market — other companies are already looking for a slice of the DNA pie. Geneaology company Ancestry.com said this month that it had a database of records it claims is larger than 23andme's with which to offer its own genetic testing, and that it was currently in the early stages of talks with the FDA.