It has been almost two years since the FDA ordered online genetic testing firm 23andMe to stop offering its health screening service. Now, the company has jumped through all the necessary regulatory hoops to begin offering health data again. However, the service will be much more narrow in focus than what it was offering previously.
23andMe offers genetic testing kits for $ 199 (sometimes less when it’s on sale), and they’ve been available this whole time. The company has always offered ancestry analysis (e.g. where in the world your genes might come from) in addition to health screening, and that part of the service was unaffected by the FDA action. Prior to the FDA-mandated end of disease reporting, 23andMe would show users the estimated likelihood they would develop a certain disease — specifically, how their risk compared to the general population.
The way 23andMe did health screening was certainly neat, and it attracted new users with the promise of mountains of data. However, as the FDA pointed out, it was often based on very limited or preliminary data. It’s not really feasible to assign a percent chance of something happening based on genes. That’s why the new 23andMe will do health analysis differently.
You’ll still get a sample collection kit in the mail to begin the process. There’s no blood to be drawn — just spit in the little plastic tube and send it off. You’ll still get all the ancestry data, but the health evaluations will now be limited to detection of disease carrier status. You’re a carrier of a disease if you have one copy of a mutated gene for a recessive disease. If you were to have a child with someone who also had that recessive gene, there’s a 25% chance the offspring will have the disease, a 50% chance they will be a carrier too, and a 25% chance they won’t have a copy of the mutated gene at all.
23andMe will be able to report carrier status for 36 serious diseases including cystic fibrosis, sickle cell disease, and Tay-Sachs. This is the same basic service that genetic counselors have been offering for some time, but for much more than $ 199. 23andMe will add new data to user reports as it gets approval from the FDA to offer more tests.
So, 23andMe has demonstrated to the FDA that its procedures for the more limited testing are accurate, but it’s unclear if people will be excited in the same way they were about the personal risk assessment. When it stopped offering health screening before, new sign-ups dropped by half. The company still hopes to gain approval to offer some health risk data like it was before, but that’s going to be a much harder sell at the FDA.
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