The settlement is one of a few that the company has made within the past several months.
The company is eliminating 155 positions.
Agency sanctions include a monetary penalty and revocation of the lab’s CLIA certificate.
In a Today Show interview, Elizabeth Holmes voices responsibility felt as a result of company problems.
There are concerns over the accuracy of direct-to-consumer tests.
A company statement aims to set the record straight.
Mainstream media attention catapulted the company to the center of controversy for its finger-prick lab tests. Now FDA has taken issue with the company’s complaint handling and design validation.