23andMe gets FDA’s approval for Bloom Syndrome test


It was more than a year ago when FDA ordered 23andMe to stop selling its DNA testing kit, which screened for 254 diseases. At that time, the agency said 23andMe didn’t receive the necessary approvals, adding that false positives for certain conditions could prompt people to seek radical surgeries or other treatments without doctors’ input.

Now, the FDA gave the company an approval for a different kind of test, one that screens for Bloom Syndrome, a rare genetic condition associated with short stature, sun sensitivity and increased cancer risk. It’s not really the same thing 23andMe was initially offering, but it’s “an important step” in the right direction. Here’s what the company said in a blog post:

While this authorization is for a single carrier status test only, we are committed to providing US customers with health information once more tests have been through this process and we have a more comprehensive product offering.

Perhaps more important for the general public is the fact that this is the first time the FDA has approved this kind of “direct-to-consumer” genetic test, which is available without physician approval. Going forward, the agency will exempt screening tests like this one, making them easier for companies to develop and sell.

[Via: TheVerge]