That was in December 2013. The Food and Drug Administration had just ruled that the company had been breaking the law in marketing its Personal Genome Service. For $99, customers spit into a tube, mailed it to 23andMe and got back a report on their carrier status or susceptibility to breast cancer, heart disease and some 250 other diseases or conditions, based on genetic information extracted from their saliva.
The FDA described the service as an unlicensed medical device and ordered it off the market. Its warning letter implied that the Mountain View, Calif., company hadn't been straight with regulators and was ignoring demands for data proving its service was accurate. Experts in the genetics testing field wondered whether the tests — and the company itself — were ready for prime time.
As of mid-October, 23andMe is back in the direct-to-consumer genetic testing business. (The firm's name refers to the 23 chromosome pairs in the human genome.) It's selling a different product, one...
The U.S. government must move “quickly and decisively” to avert substantial national security risks stemming from artificial intelligence (AI) which could, in the worst case, cause an “extinction-level threat to the human species,” says a report commissioned by the U.S...
By Nada Hassanein, New Jersey Monitor | 03.14.2024
Aggregated News
The U.S. Food and Drug Administration late last year approved two breakthrough gene therapies for sickle cell disease patients. Now a new federal program seeks to make these life-changing treatments available to patients with low incomes — and it could...
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